News

Jul 15 2021

Wugen Raises $172 Million to Advance Clinical Stage Memory NK Cell Platform, Progress Best-In-Class AML Program, and Initiate Multiple Solid Tumor Trials

Jul 15 2021
  • Proceeds to advance clinical development of WU-NK-101 for relapsed/refractory AML, and initiate studies in solid tumor indications.
  • Oversubscribed Series B co-led by Abingworth and Tybourne Capital Management, and joined by Fidelity Management & Research Company and Intermediate Capital Group (ICG) as well as existing investors RiverVest Venture Partners, LYZZ Capital, and Lightchain Capital.
  • Wugen technology licensed from Washington University in St. Louis.

ST. LOUIS, MO and SAN DIEGO, CA, July 15, 2021Wugen, Inc., a clinical stage biotechnology company developing a pipeline of off-the-shelf cell therapies, today announced the completion of an oversubscribed $172 million Series B financing led by Abingworth and Tybourne Capital Management, and joined by new investors Fidelity Management & Research Company, Intermediate Capital Group (ICG), Sands Capital, Aisling Capital Management, Alexandria Venture Investments, Velosity Capital and Falcon Edge Capital. Existing investors, including RiverVest Venture Partners, LYZZ Capital, and Lightchain Capital, also participated. In connection with the financing, Bali Muralidhar, M.D., Ph.D., Managing Partner at Abingworth, Bosun Hau, Managing Director at Tybourne Capital Management, and Peter Kiener, Ph.D., Venture Partner at ICG, will join Wugen’s Board of Directors. The proceeds of the financing will support further clinical development of Wugen’s best-in-class memory natural killer (NK) cell platform and advance ongoing trials for patients with severe acute myelogenous leukemia (AML) and other oncology indications, including solid tumors. Wugen also plans to apply these proceeds to advance its broader pipeline of next-generation products into the clinic, including its allogeneic CD7-targeted CAR-T cell therapy to treat T-cell leukemia and lymphoma.

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Jun 29 2021

Reneo Pharmaceuticals Added to the Russell 2000® and Russell 3000® Indices

Jun 29 2021

SAN DIEGO, CA – June 29, 2021 – Reneo Pharmaceuticals, Inc. (NASDAQ: RPHM), a clinical stage pharmaceutical company focused on the development and commercialization of therapies for patients with rare genetic mitochondrial diseases, joined the broad-market Russell 3000 Index at the conclusion of the 2021 Russell indexes annual reconstitution, effective after the close of the markets on June 28, 2021.

Membership in the US all-cap Russell 3000® Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000 Index or small-cap Russell 2000 Index as well as the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market capitalization rankings and style attributes.

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell’s US indexes, which are part of FTSE Russell, a leading global index provider.

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Jun 24 2021

Elevation Oncology Announces Pricing of Initial Public Offering

Jun 24 2021

NEW YORK, NY – June 24, 2021 – Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, today announced the pricing of its initial public offering of 6,250,000 shares of its common stock at a public offering price of $16.00 per share. All of the shares are being offered by Elevation Oncology. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Elevation Oncology, are expected to be $100 million. The shares are expected to begin trading on the Nasdaq Global Select Market on June 25, 2021 under the ticker symbol “ELEV.” The offering is expected to close on June 29, 2021, subject to the satisfaction of customary closing conditions. In addition, Elevation Oncology has granted the underwriters a 30-day option to purchase up to an additional 937,500 shares of common stock at the initial public offering price, less underwriting discounts and commissions.

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Jun 23 2021

Monte Rosa Therapeutics Announces Pricing of Initial Public Offering

Jun 23 2021

Boston, MA – June 23, 2021 – Monte Rosa Therapeutics, Inc. (NASDAQ: GLUE), a biotechnology company developing a portfolio of novel small molecule precision medicines that employ the body’s natural mechanisms to selectively degrade therapeutically relevant proteins, today announced the pricing of its initial public offering of 11,700,000 shares of common stock at a public offering price of $19.00 per share. All of the shares are being offered by Monte Rosa. The shares are expected to begin trading on the Nasdaq Global Select Market on June 24, 2021 under the ticker symbol “GLUE.” The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Monte Rosa, are expected to be approximately $222.3 million. The offering is expected to close on June 28, 2021, subject to the satisfaction of customary closing conditions. In addition, Monte Rosa has granted the underwriters a 30-day option to purchase up to an additional 1,755,000 shares of common stock at the initial public offering price.

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Jun 10 2021

Verona Pharma and Nuance Pharma Announce $219 Million Strategic Collaboration to Develop and Commercialize Ensifentrine in Greater China

Jun 10 2021
  • $40 million upfront including $25 million cash and $15 million in equity in Nuance Biotech (parent company)
  • Up to $179 million in potential clinical, regulatory, and commercial milestone payments plus tiered double-digit royalties
  • Nuance Pharma is responsible for all costs related to development and commercialization of ensifentrine in China

LONDON and RALEIGH, N.C. and SHANGHAI, China – June 10, 2021 – Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”) and Nuance Pharma Limited (“Nuance Pharma”), today announce that the companies have entered into an agreement granting Nuance Pharma, a Shanghai-based specialty pharmaceutical company, the rights to develop and commercialize ensifentrine in Greater China (mainland China, Taiwan, Hong Kong and Macau). Ensifentrine is an investigational, first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 (“PDE3” and “PDE4”). This dual inhibition enables it to combine both bronchodilator and anti-inflammatory effects in one compound. Verona Pharma is currently conducting a global Phase 3 program evaluating ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”), with sites in the US, Europe and South Korea.

“We are extremely excited about the formation of this strategic partnership with Nuance Pharma to further the development and future commercialization of ensifentrine in Greater China,” said David Zaccardelli, Pharm. D., President and CEO of Verona Pharma. “Nuance Pharma’s highly talented leadership team has deep experience developing and commercializing respiratory products across China and we look forward to working with them to bring ensifentrine to this important market.”

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Jun 8 2021

Aclaris Therapeutics Announces Positive Preliminary Topline Data from Phase 2a Trial of ATI-1777 for Moderate to Severe Atopic Dermatitis

Jun 8 2021
  • TI-1777 Achieved Statistically Significant Result in the Primary Efficacy Endpoint at Week 4
  • Minimal Systemic Exposure Supports “Soft” Topical JAK Inhibitor Approach
  • ATI-1777 was Generally Well Tolerated
  • Data Support Progression to Phase 2b

WAYNE, PA –  June 08, 2021 – Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced positive preliminary topline results from its first in human Phase 2a, multicenter, randomized, double-blind, vehicle-controlled, parallel-group clinical trial to evaluate the efficacy, safety, tolerability and pharmacokinetics of ATI-1777, an investigational topical “soft” JAK 1/3 inhibitor, in 50 subjects with moderate to severe atopic dermatitis (AD) (ATI-1777-AD-201). ATI-1777 is the second compound generated from Aclaris’ proprietary KINect® drug discovery platform to demonstrate positive proof of concept in clinical trials.

“We are very pleased that we achieved positive results in this trial of ATI-1777 in subjects with moderate to severe AD with minimal systemic exposure to drug,” said Dr. David Gordon, Chief Medical Officer at Aclaris. “Our approach to treating patients with moderate to severe atopic dermatitis is particularly relevant in light of some of the potential safety concerns with oral therapies.   We look forward to advancing ATI-1777 into the next phase of clinical development.”

In the trial, which consisted of a 4-week treatment period and a 2-week follow-up period during which no treatment was given, 50 subjects with moderate to severe AD were randomized in a 1:1 ratio into one of two arms: ATI-1777 topical solution 2.0% w/w or vehicle applied twice daily. One of the key objectives of this first in human trial was to assess the “soft” aspect of this topical JAK inhibitor compound in subjects with moderate to severe atopic dermatitis. A preliminary analysis of pharmacokinetic plasma samples in the ATI-1777 arm showed greater than 86% of the plasma samples had concentrations below 1 ng/ml and mean drug levels in the ATI-1777 arm (as a group) were not greater than 5% of the IC50 of ATI-1777.

The primary efficacy endpoint of this trial was the percent change from baseline in the modified Eczema Area and Severity Index (mEASI) score at week 4. The mEASI is a modified measure of EASI which excludes evaluation of the body areas that were not treated in the trial (i.e., the head, palms of hands, soles of feet, groin, or genitalia). Only the primary efficacy endpoint was powered to detect a statistically significant outcome.

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May 28 2021

BridgeBio Pharma’s Affiliate QED Therapeutics And Partner Helsinn Group Announce FDA Approval Of TRUSELTIQ™ (Infigratinib) For Patients With Cholangiocarcinoma

May 28 2021
  • Pivotal study demonstrated a clinically meaningful rate of tumor shrinkage (overall response rate) and duration of response in patients with previously-treated advanced cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement
  • BridgeBio, through its affiliate QED (“BridgeBio”), and Helsinn will co-commercialize TRUSELTIQ in the U.S.
  • TRUSELTIQ is BridgeBio’s first FDA approved therapeutic in oncology and second approved therapeutic this year

PALO ALTO, CA and LUGANO, Switzerland –  May 28, 2021 –  BridgeBio Pharma, Inc. (Nasdaq: BBIO), through its affiliate QED Therapeutics, Inc., and Helsinn Group today announced that the US Food and Drug Administration (FDA) has approved TRUSELTIQ™ (infigratinib) under the accelerated approval program for the treatment of patients with previously-treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement. TRUSELTIQ is an orally administered, ATP-competitive, tyrosine kinase inhibitor of FGFR. In the pivotal trial of patients with advanced, unresectable CCA, an aggressive malignancy with poor prognosis, TRUSELTIQ led to cases of tumor shrinkage. CCA is known to affect approximately 20,000 people in the United States and European Union each year and has a median five-year survival rate of only 9%.1

“This is an important milestone for patients diagnosed with FGFR2-fusion-driven cholangiocarcinoma who have recurred after first-line therapy and are in need of targeted options for further treatment,” said Susan Moran, M.D., M.S.C.E., Chief Medical Officer for QED. “Based on the efficacy seen to date, our team believes infigratinib possesses promise for a range of FGFR-driven conditions, including other cancers. We will continue to evaluate its safety and efficacy in these areas of unmet need.”

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May 14 2021

BridgeBio Pharma Receives FDA Fast Track Designation For Investigational Gene Therapy For Congenital Adrenal Hyperplasia

May 14 2021
  • Preclinical Data for Congenital Adrenal Hyperplasia and Canavan Disease Programs Shared at American Society of Gene & Cell Therapy Annual Meeting, Enabling Anticipated Clinical Trials This Year
PALO ALTO, CA – May 14, 2021 — BridgeBio Pharma, Inc. (Nasdaq: BBIO), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to BBP-631, an investigational adeno-associated virus 5 (AAV5) gene therapy designed for the treatment of congenital adrenal hyperplasia (CAH).Fast Track designation, granted by the FDA, is designed to facilitate the development and to expedite the review of new therapies hoping to treat or prevent serious conditions and fill an unmet medical need. Additionally, BBP-631 was granted Rare Pediatric Disease Designation by the FDA and has received Orphan Drug Designation by the FDA and European Medicines Agency (EMA).“The standard-of-care for CAH patients has not changed significantly over the last 50 years, and a gene therapy offers for the first time the possibility that patients may be able to make their own cortisol and aldosterone, at the right times and in the right amounts. The FDA’s Fast Track designation reinforces the urgency to address the unmet needs of patients with CAH as quickly and safely as possible. We are grateful to have received Fast Track along with other key designations granted by the FDA and the EMA,” said Eric David, M.D., J.D., CEO at BridgeBio Gene Therapy, which is focused on developing gene therapy treatment options for patients in need. “We are eager to initiate our first-in-human Phase 1/2 study. The Investigational New Drug application has been cleared by the FDA and site activation for the study is ongoing, and is expected to begin in the coming months.”CAH is one of the most prevalent genetic diseases with more than 75,000 cases estimated in the United States and Europe. The disease is caused by deleterious mutations in the gene encoding an enzyme called 21-hydroxylase, leading to lack of endogenous cortisol and aldosterone production. This lack of production causes patients with CAH to be unable to form physiological responses to illnesses and stressors, which can be life-threatening, especially for children. BBP-631 is designed to provide a functional copy of the 21-hydroxylase-encoding gene to help patients produce their own cortisol and aldosterone.

Additionally, BridgeBio Gene Therapy presented preclinical data from its CAH program on May 13, 2021 at the American Society of Gene & Cell Therapy (ASGCT) annual meeting, being held virtually May 11-14, 2021. The presentation covered three key Investigational New Drug (IND)-enabling studies that informed the anticipated upcoming clinical trial for BBP-631, which is expected to begin in late 2021. The IND application has been cleared by the FDA and site activation for initiation of a first-in-human Phase 1/2 study is ongoing, with initial data anticipated in late 2021 or early 2022.  At ASGCT, BridgeBio Gene Therapy today will also be presenting preclinical data from its program designed for the treatment of Canavan disease, which is an extremely rare genetic disease starting in infancy with an incidence of approximately one in 100,000 births worldwide.

“ASGCT is an important opportunity to share the robust preclinical data package underlying our programs. We hope that by rapidly advancing our investigational therapies into the clinic, we will be one step closer to providing CAH and Canavan patients with potential therapeutic relief,” said Clayton Beard, senior vice president of research and development at BridgeBio Gene Therapy.

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May 11 2021

Talaris Therapeutics Announces Closing of Initial Public Offering

May 11 2021

BOSTON and LOUISVILLE, KY – May 11, 2021 – Talaris Therapeutics, Inc. (Nasdaq: TALS), a late-clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation, certain severe autoimmune diseases, and certain severe non-malignant blood, immune and metabolic disorders, today announced the closing of its initial public offering of 8,825,000 shares of its common stock at a price to the public of $17.00 per share. The gross proceeds of the offering were approximately $150.0 million, before deducting underwriting discounts and commissions and other offering expenses. The shares began trading on the Nasdaq Global Market on May 7, 2021 under the symbol “TALS.” All shares in the offering were offered by Talaris Therapeutics. In addition, the underwriters have a 30-day option to purchase up to an additional 1,323,750 shares of common stock at the initial public offering price less underwriting discounts and commissions.

Morgan Stanley, SVB Leerink, Evercore ISI and Guggenheim Securities are acting as joint book-running managers for the offering.

A registration statement relating to these securities has been filed and was declared effective by the Securities and Exchange Commission on May 6, 2021. This offering was made only by means of a written prospectus. Copies of the final prospectus relating to the initial public offering can be obtained, when available, from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@svbleerink.com; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at (888) 474-0200, or by email at ecm.prospectus@evercore.com; and Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-5548, or by email at GSEquityProspectusDelivery@guggenheimpartners.com.

 

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Apr 20 2021

Biomea Announces Closing of Initial Public Offering

Apr 20 2021

REDWOOD CITY, CA – April 20, 2021 – Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a preclinical-stage biopharmaceutical company focused on the discovery, development and commercialization of irreversible small molecules to treat patients with genetically defined cancers, today announced the closing of its initial public offering of 9,000,000 shares of its common stock at a public offering price of $17.00 per share. All of the shares of common stock were offered by Biomea. Biomea’s common stock began trading on The Nasdaq Global Select Market on April 16, 2021 under the ticker symbol “BMEA.” The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Biomea, were $153.0 million. In addition, Biomea has granted the underwriters a 30-day option to purchase up to an additional 1,350,000 shares of common stock at the initial public offering price, less the underwriting discounts and commissions and offering expenses.

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