The Daily Biotech Pulse: Regeneron-Sanofi Halt Late-Stage Dupixent Study, Agios Gets FDA Nod, Safety Scare For GSK's RSV Vaccine, Shockwave Jumps On Earnings

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

Stocks In Focus

Agios's Metabolic Disorder Treatment Receives FDA Approval

AGIO said the U.S. Food and Drug Administration has approved its Pyrukynd (mitapivat) in the U.S. for the treatment of hemolytic anemia in adults with pyruvate kinase deficiency, a rare, debilitating, lifelong hemolytic anemia, or an accelerated destruction of red blood cells.

The company said it expects the treatment to be made available in the U.S. two weeks after the approval.

The stock was up 2.95% to $30.33 in premarket trading.

Click here to access Benzinga's FDA Calendar

Regeneron, Sanofi Halt Late-Stage Study Of Dupixent In Treating Skin Rash

Regeneron Pharmaceuticals, Inc. REGN and Sanofi SNY announced a Phase 3 trial evaluating their co-developed Dupixent in patients with chronic spontaneous urticaria will stop due to futility, based on a pre-specified interim analysis.

The trial, which assessed Dupixent added to antihistamines in patients refractory to omalizumab at 24 weeks, showed positive numerical trends in reducing itch and hives but didn't meet statistical significance during an interim analysis conducted by an independent review committee, the companies said.

GlaxoSmithKline To Pause Late-Stage Study Of RSV Maternal Vaccine Candidate

GlaxoSmithKline plc GSK announced that it has voluntarily paused enrolment and vaccination in the GRACE phase 3 trial evaluating its potential respiratory syncytial virus maternal vaccine candidate, as well as two other trials investigating this candidate in pregnant women.

This decision was made following a recommendation from the Independent Data Monitoring Committee based on an observation from a routine safety assessment.

Novartis' Sandoz Unit Announces Generic Launch Of Revlimid In Europe

Novartis AG's NVS Sandoz generic unit announced the launch of generic version of Bristol-Myers Squibb Company's BMY oncology drug Revlimid, indicated for several haemato-oncology conditions. The company said the medicine will become available to patients in 19 countries across Europe.

Earnings

Shockwave Medical, Inc. SWAV said its fourth-quarter revenues climbed 271% to $84.2 million, helped by the launch of its coronary product Shockwave C. The company reversed from a loss of 46 cents per share to a profit of 34 cents per share. Shockwave issued 2022 revenue guidance that exceeded expectations.

The stock was gaining 11.30% to $159 in premarket trading.

Quidel Corporation's QDEL fourth-quarter revenues climbed from $636.9 million in 2020 to $809.2 million in 2021.The non-GAAP EPS slid from $11.07 to $7.29 but exceeded the consensus estimate of $5.61 per share.
In premarket trading, the stock was moving up 6.85% to $94.40.

Prothena Corporation plc PRTA reported collaboration revenues of $1.172 million and a net loss per share of 71 cents, which was more than the 58 cents per share loss expected by analysts.

The stock was slipping 11.58% to $31 in premarket trading.

Globus Medical, Inc. GMED said its worldwide sales rose 7.1% to $250 million and non-GAAP EPS came in at 49 cents, ahead of the consensus estimate of 47 cents per share.

For fiscal-year 2022, the company guided to net sales of $1.025 billion and non-GAAP EPS of $2.10, with both metrics trailing the consensus estimates.

The stock was moving down 2.92% to $64.40 in premarket trading.

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

On The Radar

Clinical Readouts/Presentations

ASCO Genitourinary Cancers Symposium Presentations

AstraZeneca plc. AZN: results of the BAYOU Phase 2 trial evaluating the combination of Lynparza and Imfinzi in unresectable, Stage IV bladder cancer (5:42 pm – 5:52 pm)