Biotech News Brief

Biotech news for Tuesday, May 19, 2026, ranked by our 5-dimension investment framework — regulatory, technology, commercial, manufacturing, and narrative.

May 16, 8:55 AM EDT

Regeneron hit with late-stage trial setback for Libtayo combo against Merck’s Keytruda

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peterschreiber.media Regeneron ( REGN ) has announced a failure in a late-stage trial designed to evaluate a combination therapy involving its anti-PD-1 immunotherapy Libtayo against pembrolizumab, Merck’s ( MRK ) blockbuster cancer therapy marketed as Keytrud…

May 16, 8:23 AM EDT

Amgen’s Tavneos reportedly linked to 20 deaths in Japan

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Mario Tama/Getty Images News Twenty people died in Japan after receiving Tavneos, a rare disorder therapy developed by Amgen ( AMGN ), prompting its local partner Kissei ( KSPHF ) to urge healthcare professionals to exercise caution in prescribing the drug, Th…

May 15, 9:32 PM EDT

Ars Pharmaceuticals anticipates CVS Caremark decision as it expands $199 retail access program

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Earnings Call Insights: ARS Pharmaceuticals (SPRY) Q1 2026 Management view “We are off to a strong start in 2026... building momentum across the business,” said (Co-Founder, President, CEO & Director Richard Lowenthal), highlighting priorities of “expandin…

May 15, 6:21 PM EDT

BioCardia outlines Japan Shonin filing in ~7 months and targets ~19-month path to approval for CardiAMP

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Earnings Call Insights: BioCardia (BCDA) Q1 2026 Management View "We have had significant accomplishments this last quarter for our CardiAMP Cell Therapy for the treatment of ischemic heart failure" (CEO, President & Director Peter Altman), highlighting FD…

May 15, 4:51 PM EDT

MiNK outlines 90-patient randomized Phase II ARDS trial with initial data expected in 2H 2026

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Earnings Call Insights: MiNK Therapeutics (INKT) Q1 2026 Management View Dr. Jennifer Buell (Co-Founder, President, CEO & Director) framed recent disclosures around clinical and mechanistic readouts across oncology and pulmonary indications, saying, "Over…

May 15, 4:16 PM EDT

Enlivex receives Nasdaq non-compliance notice over sub-$1 share price

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Enlivex( ENLV ) was notified by Nasdaq that its share price stayed below the $1 minimum bid requirement for 30 consecutive business days. The company has until November 9, 2026, to regain compliance. If compliance is not restored by the deadline, Enlivex may q…

May 15, 2:00 PM EDT

Genentech gains bladder cancer indication for Tecentriq

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The FDA has approved Roche ( RHHBY )-owned Genentech's oncologic Tecentriq ( atezolizumab) as an adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC). The new indication is specifically for individuals who have circulating tumor DNA…

May 15, 1:32 PM EDT

FDA leadership fallout continues as acting CDER Director Hoeg departs

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JHVEPhoto Editor's note: This story was updated at 515p ET citing a Bloomberg report that Hoeg has left her position. Just days after Marty Makary left as FDA commissioner on May 12, Tracey Beth Hoeg, the acting leader of the agency's Center for

May 15, 10:41 AM EDT

ImmuCell outlines capacity expansion plan backed by $2M settlement while focusing on First Defense

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Earnings Call Insights: ImmuCell Corporation (ICCC) Q1 2026 Management View CEO P. F. Te Boekhorst said the company is “starting to see the results” of its late-2025 shift toward the calf scours market and manufacturing yield improvement, highlighting “our fir…