News

Nov 18 2020

Elevation Oncology Announces $65M Series B Financing and Promotion of Founder Shawn M. Leland to Chief Executive Officer

Nov 18 2020

NEW YORK, NY – November 18, 2020 – Elevation Oncology, a clinical-stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, announced today a Series B financing of $65 million led by new investors, venBio Partners and Cormorant Asset Management, and the promotion of Shawn M. Leland, PharmD, RPh, the Company’s founder, to Chief Executive Officer. Additional participants in the financing include Boxer Capital of Tavistock Group, Janus Henderson, Samsara Biocapital, and Vivo Capital, as well as all of Elevation Oncology’s existing investors: Aisling Capital, Vertex Ventures HC, Qiming Venture Partners USA, Driehaus Capital Management, and BVF Partners.

Andrew Phillips, PhD from Cormorant Asset Management and Richard Gaster, MD, PhD from venBio Partners will join the Elevation Oncology Board of Directors in conjunction with the new financing.

“We welcome Andy and Rich to our Board of Directors and are encouraged by the support of a highly sophisticated investor group committed to helping us continue to pursue our mission,” said Dr. Leland. “At the core of Elevation Oncology is the belief that patients deserve the right clinical team and the right genomic tests to match the right therapeutics to the unique genomic profile of each tumor. We look forward to continuing to work closely with our Board and Scientific Advisors to innovate and accelerate the development of precision oncology therapeutics to realize this vision.”

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Oct 13 2020

Harmony Biosciences Receives FDA Approval for Expanded Use of WAKIX® (Pitolisant) for the Treatment of Cataplexy in Adult Patients with Narcolepsy

Oct 13 2020

WAKIX is the first and only non-scheduled treatment approved for excessive daytime sleepiness or cataplexy in adult patients with narcolepsy

PLYMOUTH MEETING, PA and CHICAGO, IL, October 13, 2020 — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the U.S. Food and Drug Administration (FDA) has approved WAKIX® (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

“All people living with narcolepsy have excessive daytime sleepiness and up to two-thirds of them also experience cataplexy, which is one of the most debilitating symptoms of this chronic, rare neurological disorder,” said Harmony’s Chief Medical Officer, Jeffrey Dayno, M.D. “Today’s FDA approval of the cataplexy indication for WAKIX, coupled with it being the first and only non-scheduled treatment option approved for adult patients with narcolepsy to treat both excessive daytime sleepiness or cataplexy, provides an opportunity for WAKIX to offer broad clinical utility to healthcare professionals managing adult patients living with narcolepsy.”


Oct 8 2020

Spruce Biosciences Announces Pricing of Upsized Initial Public Offering

Oct 8 2020

SAN FRANCISCO, CA – October, 8, 2020 – Spruce Biosciences, Inc., a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet need, today announced the pricing of its initial public offering of 6,000,000 shares of its common stock at a public offering price of $15.00 per share, before underwriting discounts and commissions. The shares are expected to begin trading on the Nasdaq Global Select Market on October 9, 2020 under the symbol “SPRB”. In addition, Spruce has granted the underwriters a 30-day option to purchase up to an additional 900,000 shares of common stock at the public offering price less underwriting discounts and commissions.

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Oct 6 2020

Talaris Therapeutics Closes $115 Million Series B Financing

Oct 6 2020

Proceeds to support ongoing Phase 3 registration trial of Talaris’ lead product candidate FCR001 in living donor kidney transplant, and additional Phase 2 trials next year in autoimmune disease and organ transplant

Financing co-led by Surveyor Capital (a Citadel company) and Viking Global Investors, with multiple new investors participating –

BOSTON, MA and LOUISVILLE, KY – October 6, 2020  Talaris Therapeutics, Inc., a privately held biotechnology company developing transformative cell therapies that have the potential to induce durable immune tolerance across a range of indications, announced the closing of a $115 million Series B financing co-led by Surveyor Capital (a Citadel company) and Viking Global Investors.

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Sep 24 2020

Monte Rosa Therapeutics Announces $96 Million Series B Financing to Advance Small Molecule-based Protein Degradation Platform

Sep 24 2020

Company’s “Molecular Glue” Degraders Represent New Approach to Selectively Eliminate Disease-causing Proteins in Cancer and Beyond

BOSTON, MA – September 24, 2020 – Monte Rosa Therapeutics, a biotechnology company focused on developing precision medicines to degrade disease-causing proteins, announced today the closing of a Series B financing of $96 million. This financing will enable Monte Rosa to accelerate the growth of its pipeline, advance development candidates into the clinic and bolster its platform capabilities to rationally design and develop small molecule degraders (also known as molecular glues) that hijack the body’s innate ability to degrade proteins. Through this approach Monte Rosa Therapeutics will eradicate undruggable proteins that cause or drive the progression of genomically defined diseases intractable to standard care, including cancer.

The Series B financing was led by Aisling Capital with participation from founding investor Versant Ventures and existing investor New Enterprise Associates. Additional new investors included HBM Healthcare Investments, Cormorant Asset Management, GV, Amzak Health, Casdin Capital, Sixty Degree Capital and Cambridge Asset Management.

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Aug 31 2020

Aimmune Agrees to be Acquired by Nestlé Health Science

Aug 31 2020
  • Sociétés des Produits Nestlé S.A., part of Nestlé Health Science, to acquire Aimmune for $34.50 per share in cash, representing a total equity value of $2.6 Billion and a 174% premium to Aimmune’s closing price on August 28, 2020
  • Aimmune’s PALFORZIA® [Peanut (Arachis hypogaea) Allergen Powder-dnfp] is the world’s first approved treatment for peanut allergy
  • Transaction expected to be completed in the fourth quarter of 2020

BRISBANE, Calif.–(BUSINESS WIRE)–Aug. 31, 2020– Aimmune Therapeutics Inc. (Nasdaq: AIMT), a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies, today announced that it has entered into a definitive agreement for Sociétés des Produits Nestlé, S.A. to acquire Aimmune for $34.50 per share in an all-cash transaction, implying a fully-diluted equity value of $2.6 billion. Sociétés des Produits Nestlé, S.A. is a part of Nestlé Health Science (NHSc) and a wholly owned subsidiary of Nestlé S.A. The agreement was unanimously approved by all of the independent members of the Board of Directors of Aimmune. Greg Behar, CEO of Nestlé Health Sciences and an Aimmune Director, abstained due to his position with Nestlé Health Science.

The transaction is expected to close in the fourth quarter of 2020, pending the satisfaction of all conditions to the completion of the tender offer. Until that time, Aimmune will continue to operate as a separate and independent company.

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Aug 21 2020

Harmony Biosciences Announces Closing of its Upsized Initial Public Offering and Exercise in Full of Underwriters' Option to Purchase Additional Shares

Aug 21 2020

PLYMOUTH MEETING, PA and CHICAGO, IL, August 21, 2020 Harmony Biosciences Holdings, Inc. (“Harmony”), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced it has closed its upsized initial public offering of 6,151,162 shares of common stock, including 802,325 shares sold pursuant to the exercise in full of the underwriters’ option to purchase additional shares of common stock, at the public offering price of $24.00 per share. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Harmony, are expected to be $147.6 million. All of the shares were offered by Harmony.

Harmony shares began trading on the Nasdaq Global Market under the ticker symbol “HRMY” on August 19, 2020.

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Aug 6 2020

Zosano Pharma Announces Partnership Agreement with EVERSANA to Support the Launch and Commercialization of Qtrypta™

Aug 6 2020

Agreement outlines commercialization and distribution execution strategy upon FDA approval

EVERSANA to provide commercial services of approximately $250 million over 5 years

FREMONT, Calif., Aug. 06, 2020 (GLOBE NEWSWIRE) — Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced it has partnered with EVERSANA, a leading provider of commercial services to the life science industry, to commercialize and distribute Qtrypta™ in the United States. Qtrypta is Zosano’s transdermal microneedle product candidate for the acute treatment of migraine. In March, the U.S. Food and Drug Administration (FDA) accepted a New Drug Application for Qtrypta and granted a Prescription Drug User Fee Act (PDUFA) goal date of October 20, 2020. If approved, Qtrypta would be the first and only microneedle patch indicated for the acute treatment of migraine.

Zosano and EVERSANA will utilize EVERSANA’s commercial execution expertise for marketing, market access, distribution, sales force deployment, reimbursement, and patient adherence support services. To optimize performance, EVERSANA’s integrated data and analytics platform will analyze fully integrated data, predict product and patient needs, and inform commercial activities at launch of Qtrypta and thereafter.

Under the terms of the agreement, the parties will cooperate to conduct activities over the term of the agreement pursuant to an anticipated $250 million commercialization budget for Qtrypta. Zosano maintains ownership of the Qtrypta New Drug Application as well as all legal, regulatory, and manufacturing responsibilities for the product. EVERSANA receives exclusive right to conduct agreed commercialization activities, and will utilize its internal sales organization along with its other commercial capabilities for market access, marketing, distribution and patient support services for Qtrypta. EVERSANA will receive reimbursement of certain costs and a low double digit percentage of product profits when Zosano net sales surpass certain costs incurred by the parties pursuant to the commercialization budget. Zosano and EVERSANA retain the right to terminate the agreement upon certain events, including Zosano’s right to terminate upon any change of control of Zosano. The term of the agreement is five years following the date of FDA approval.

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Jul 28 2020

Nabriva Receives European Approval for XENLETA® (lefamulin) for Treatment of Community-Acquired Pneumonia (CAP)

Jul 28 2020

XENLETA represents the first new antibiotic class approved for patients with CAP in Europe in nearly 20 years

XENLETA approval provides urgently needed short-course, empiric monotherapy treatment option for CAP aligned with core principles of antimicrobial stewardship

DUBLIN, July 28, 2020 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV) announced today that the European Commission (EC) has issued a legally binding decision for approval of the marketing authorization application for XENLETA™ (lefamulin) for the treatment of community-acquired pneumonia (CAP) in adults following a review by the European Medicines Agency (EMA). The EMA approval of XENLETA in CAP patients when it is considered inappropriate to use antibacterial agents that are commonly recommended for initial treatment or when these agents have failed paves the way for the launch of XENLETA across Europe. The U.S. Food and Drug Administration (FDA) approved XENLETA for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) in August 2019.

The EMA approval is based on efficacy data from the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 studies and a safety database of 1,242 study participants. In the two Phase 3 clinical trials, the European Medicines Agency’s co-primary endpoint was the Investigator Assessment of Clinical Response (IACR) at Test of Cure (TOC) in both the clinically evaluable (CE) and modified intent-to-treat (mITT) populations. Both studies established XENLETA to be non-inferior to the standard-of-care moxifloxacin in the treatment of adults with CAP independently and when the pooled data were analyzed across PORT scores of II-V.  In the pooled analysis, the IACR success rate at TOC in the modified Intent-to-Treat (mITT) population was 85 percent in the XENLETA group and 87.1 percent in the moxifloxacin group (treatment difference ‑2.2 percent; 95 percent confidence interval (CI): ‑5.9, 1.6), and 88.5 percent in the lefamulin group and 91.8 percent in the moxifloxacin group (treatment difference ‑3.3 percent; 95 percent CI: ‑6.8, 0.1) in the clinically evaluable population. In these trials, lefamulin was generally well-tolerated.  The most frequently reported adverse reactions were administration site reactions, diarrhea, nausea, vomiting, hepatic enzyme elevation, headache, hypokalemia and insomnia.

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Jul 21 2020

Elevation Oncology Emerges from Stealth with $32.5M Series A to Develop Precision Medicines for Tumors Harboring Rare Genetic Driver Alterations

Jul 21 2020

– $32.5M Series A Financing Led by Aisling Capital, Vertex Ventures HC, Qiming Venture Partners USA, Driehaus Capital Management, and BVF Partners –

– Registration-Enabling Phase 2 CRESTONE Study Now Enrolling Patients with Solid Tumors of Any Origin that have an NRG1 Gene Fusion –

– CRESTONE Enrollment Enhanced Through Strategic Partnerships with Next Generation Sequencing Diagnostic Providers Including Ashion Analytics, Strata Oncology, and Tempus to Advance Patient Enrollment Practices for Genomically-driven, Tumor-agnostic Clinical Trials –

NEW YORKJuly 21, 2020 /PRNewswire/ — Elevation Oncology, a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, announced today the launch of the Company with a $32.5M Series A financing, initiation of the Phase 2 CRESTONE study, and new partnerships with Next Generation Sequencing diagnostic providers including Ashion AnalyticsStrata Oncology, and Tempus to explore innovative models for real-time identification, patient referral, and enrollment of patients with tumors driven by rare genomic alterations. The Series A financing was led by Aisling Capital and a syndicate of investors including Vertex Ventures HC, Qiming Venture Partners USA, Driehaus Capital Management, and BVF Partners.

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