News

SAN DIEGO, CA - December 18, 2020 - Poseida Therapeutics, Inc. (NASDAQ: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary gene engineering platform technologies to create cell and gene therapeutics with the capacity to cure, today announced that it has been selected for addition to the NASDAQ Biotechnology Index^® (Nasdaq: NBI). Addition to the NBI will become effective prior to market open on Monday, December 21, 2020. The NASDAQ Biotechnology Index is designed to track the performance of a set of securities listed on The Nasdaq Stock Market^® (Nasdaq^®) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark (ICB). Companies in the NBI must meet eligibility requirements, including minimum market capitalization and average daily trading volume, among other criteria. The Index is evaluated annually and serves as the basis for the iShares NASDAQ Biotechnology Index Fund (Nasdaq: IBB). For more information about the NASDAQ Biotechnology Index, including eligibility criteria, visit https://indexes.nasdaqomx.com/Index/Overview/NBI.

WALTHAM, MA - December 18, 2020 -  Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that the Company has been selected for addition to the NASDAQ Biotechnology Index^® (NASDAQ: ^NBI), effective prior to market open on Monday, December 21, 2020. The NASDAQ Biotechnology Index was launched in 1993 and is designed to track the performance of a set of securities listed on the NASDAQ Stock Market^® (NASDAQ) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark. Companies in the NBI must meet eligibility requirements, including an average daily trading volume, minimum market capitalization, and other criteria. The index is evaluated annually and serves as the basis for the iShares NASDAQ Biotechnology Index Fund. For more information about the NASDAQ Biotechnology Index, including eligibility criteria, please visit https://indexes.nasdaqomx.com/-Index/Overview/NBI.

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.”

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."

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.

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.

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

• 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.

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.

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.