The Daily Biotech Pulse: FDA Approves Bristol Myers' Oral Heart Disease Drug, European Approval For Merck's Keytruda, Genocea Restructures, Zymeworks' Takeover Bid

Here's a roundup of top developments in the biotech space over the last 24 hours.

Stocks In Focus

Bristol Myers' Oral Heart Disease Drug Scores FDA Approval

The FDA has approved Bristol Myers Squibb & Co's BMY Camzyos (mavacamten) for obstructive hypertrophic cardiomyopathy (obstructive HCM) to improve functional capacity and symptoms.

Camzyos is the first and only FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of obstructive HCM.

Back-To-Back European Approval For Merck's Keytruda In Various Cancer Indications

The European Commission has approved Merck & Co Inc's MRK Keytruda plus chemo, with or without bevacizumab, for persistent, recurrent, or metastatic cervical cancer in adults whose tumors express PD-L1.

Europe has also approved Keytruda monotherapy for microsatellite instability-high or deficient mismatch repair tumors in five different types of cancer.

The approval covers patients who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and are not candidates for curative surgery or radiation.

Zymeworks Confirms $10.50/Share Takeover Bid

Zymeworks Inc ZYME confirmed it received an unsolicited, non-binding proposal from All Blue Falcons FZE and its affiliates to purchase the company for $10.50 per share. The Zymeworks board of directors will carefully review the proposal. 

Shares are up 49.2% at $7.20 in the premarket session.

Click here to access Benzinga's FDA Calendar.

Genocea Initiates Restructuring, Explores Strategic Alternatives

Genocea Biosciences Inc GNCA is exploring strategic alternatives and has engaged professional advisors, including an investment bank, to act as a strategic advisor for this process. 

The company will reduce its workforce by approximately 65% in the second quarter of 2022 and is reviewing its clinical and research programs.

Shares closed 25.1% lower at 31 cents during after-hours trading.

Annovis Bio Inks CRADA Agreement To Develop Pharmacodynamic Biomarkers for Buntanetap

Annovis Bio Inc ANVS announced a Cooperative Research and Development Agreement (CRADA) with the National Institute on Aging (NIA), a part of the National Institutes of Health. 

Under this CRADA, NIA and Annovis will collaborate to develop pharmacodynamic biomarkers for buntanetap, focusing on isolating brain-derived extracellular vesicles containing potential neuronal function and viability biomarkers.

FDA Removes Clinical Hold On Finch Therapeutics' C. difficile infection

The FDA has removed the clinical hold on Finch Therapeutics Group Inc's FNCH investigational new drug application for CP101, an orally administered microbiome therapeutic, which is in Phase 3 study for recurrent C. difficile infection. 

The FDA lifted the clinical hold following a review of information Finch provided related to its SARS-CoV-2 screening procedures and associated informed consent language.

Shares are trading 46% higher at $3.07 in the premarket session.

Aldeyra's CFO Transition

Aldeyra Therapeutics Inc's ALDX CFO and Treasurer Joshua Reed tendered his resignation to pursue other career opportunities. 

He will continue to serve in his current role until May 10. 

Effective as of the Resignation Date, Aldeyra plans to appoint its current Vice President and Controller, Bruce Greenberg, to serve as its Vice President of Finance, Interim CFO, and Treasurer.

Dosing In Monalizumab Lung Cancer Trial Triggers $50M Payment From AstraZeneca To Innate Pharma

Innate Pharma SA IPHA announced that AstraZeneca Plc AZN has started dosing in its Phase 3 trial, PACIFIC-9, evaluating durvalumab (PD-L1) combined with monalizumab (NKG2A) or AstraZeneca's oleclumab (anti-CD73) in non-small cell lung cancer.

Insider Trading

Vaxxinity Inc VAXX: Executive chairman Lou Reese purchased 22,912 shares at $3.48/share.

Offering

Abeona Therapeutics Inc (NASDAQ: ABEO has announced a private placement of convertible redeemable preferred stock of $25 million, including 1 million shares of Series A convertible redeemable preferred stock and 250,005 shares of Series B convertible redeemable preferred stock. 

Each share of Series A and Series B preferred stock has a purchase price of $19.00. 

Each share of Series A and Series B preferred stock is convertible at an initial conversion price of 45 cents per share. 

On The Radar

Data Presentation

ProQR Therapeutics N.V. PRQR: Several presentations at the Retinal Cell and Gene Therapy Innovation Summit.

PDUFA Dates

The FDA is scheduled to decide on the expanded use of Supernus Pharmaceuticals Inc's SUPN Qelbree (viloxazine extended-release capsules) for attention-deficit hyperactivity disorder (ADHD) in adult patients.

IPOs

Belite Bio Inc BLTE

Hillevax Inc HLVX

Earnings

Bristol-Myers Squibb Co BMY (Before Market Open).

AstraZeneca plc AZN (Before Market Open).

AbbVie Inc ABBV (Before Market Open).

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