The Daily Biotech Pulse: Lilly's Jardiance Gets Nod For Heart Failure, Pulmatrix Announces Reverse Split, Reata Awaits FDA Decision

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

Stocks In Focus

Lilly's Co-developed Diabetes Drug Jardiance Gets Label Expansion To Treat Hear Failure

Lilly & Company, Inc. LLY announced the U.S. Food and Drug Administration has approved Jardiance, 10 mg, to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. Lilly is co-developing the drug with Boehringer Ingelheim.

Pliant Commences Mid-stage Study of Idiopathic Pulmonary Fibrosis Treatment Following Positive Independent Safety Review

Pliant Therapeutics, Inc. PLRX said, following a positive independent Data Safety Monitoring Board safety review, it has begun rolling in a Phase 2a trial of PLN-74809 at 320 mg dosed once daily for at least six months in patients with idiopathic pulmonary fibrosis.

The stock was up 2.02% at $8.59 in premarket trading.

Aquestive Announces FDA Clearance For Study Of Allergy Treatment Candidate AQST-109

Aquestive Therapeutics, Inc. AQST announced the clearance of its investigational new Drug Application from the FDA for its drug candidate AQST-109 epinephrine oral film for the emergency treatment of severe allergic reactions, including anaphylaxis.
Separately, the company announced positive topline results from Part 1 of the EPIPHAST study for its AQST-109 epinephrine oral film.

Valneva Says EMA Committee Raises Questions Regarding Its COVID-19 Vaccine Candidate

Valneva SE VALN announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has raised a list of questions regarding its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.

The company said it expects to respond to these in the coming days. Following the company's response, the EMA will provide a timetable towards anticipated conditional approval.

The stock was slipping 0.35% to $32.48 in premarket trading.

Immunocore's Eye Cancer Drug Gets Positive Opinion From EMA Committee

Immunocore Holdings plc IMCR announced the EMA's CHMP has adopted a positive opinion recommending the approval of Kimmtrak for the treatment of adult patients with unresectable or metastatic uveal melanoma.

Pulmatrix Announces 1-For-20 Reverse Stock Split

Pulmatrix, Inc. PULM announced a 1-for-20 reverse split of its common stock, to be effective as of close of trading on Feb. 28. The common stock is expected to trade on the Nasdaq on a split-adjusted-basis when the market opens on March 1.

The stock was down 14.40% at 31.99 cents in premarket trading.

Related Link: Attention Biotech Investors: Mark Your Calendar For These Key February PDUFA Dates

Earnings

Aerie Pharmaceuticals, Inc. AERI reported a sharp increase in fourth-quarter net revenues to $114.7 million in 2021 from $24.7 million in 2020. The company's non-GAAP net income increased from 79 cents to $1.09. The company guided to 2022 Glaucoma franchise net product revenue of $130 million to $140 million.

The stock was gaining 10.17% to $6.50 in premarket trading.

OPKO Health, Inc.'s OPK fourth-quarter revenues slipped from $494.6 million in 2020 to $401.3 million in 2021. The company reversed from a profit of 5 cents per share to a loss of 11 cents per share.

The stock was slipping 13.31% to $2.80 in premarket trading.

Offerings

Baudax Bio, Inc. BXRX priced its previously announced underwritten public offering of 3.51 million shares of common stock, together with warrants to purchase up to an aggregate of 3.51 million shares of common stock.

Each share of common stock is being sold together with one warrant to purchase one share of common stock at a combined public offering price of $2.85 per share of common stock and accompanying warrant.

The stock was plunging 55.02% to $1.97 in premarket trading.

On The Radar

PDUFA Dates

The FDA has set a PDUFA date of Feb. 25 for its new drug application for Reata Pharmaceuticals, Inc.'s RETA Bardoxolone. The investigational compound is a once-daily, orally administered drug that is being evaluated as a treatment option for Alport syndrome is a rare, genetic form of chronic kidney disease caused by mutations in the genes.

Earnings

Biohaven Pharmaceutical Holding Company Ltd. BHVN (before the market open)
ImmunoGen, Inc. IMGN (before the market open)