Biotech News Brief

Biotech news for Thursday, May 14, 2026, ranked by our 5-dimension investment framework — regulatory, technology, commercial, manufacturing, and narrative.

May 14, 4:41 AM EDT

Dyadic outlines cash runway into Q2 2027 while targeting mid-2026 alpha-lactalbumin sampling

DYAI

Earnings Call Insights: Dyadic International (DYAI) Q1 2026 Management View “Over the last several years, we have worked to transform Dyadic from a platform technology company into a commercially focused biotechnology company capable of generating recurring re…

May 14, 12:41 AM EDT

Altimmune outlines PERFORMA Phase III MASH start in 2H 2026 and cash runway to 2029 52-week readout

ALT

Earnings Call Insights: Altimmune (ALT) Q1 2026 Management View "In April, we completed an oversubscribed public offering resulting in $225 million in gross proceeds" and "the proceeds from the April offering, along with our existing funds, resulted in a cash…

May 13, 10:41 PM EDT

Precigen anticipates funding through cash flow breakeven by end of 2026 as PAPZIMEOS launch scales

PGEN

Earnings Call Insights: Precigen (PGEN) Q1 2026 Management View "The accelerating trajectory we are seeing in revenue growth is robust." (President, CEO & Director Helen Sabzevari) "PAPZIMEOS' net product revenue for Q1 2026, the first full quarter of avai…

May 13, 9:31 PM EDT

Inovio outlines cash runway into Q1 2027 as INO-3107 targets October 30, 2026 PDUFA date

INO

Earnings Call Insights: Inovio Pharmaceuticals (INO) Q1 2026 Management View "These are very busy times at Inovio as we remain focused on achieving our top priority, advancing our lead candidate, INO-3107 through the regulatory process and toward its October 3…

May 13, 8:51 PM EDT

Longeveron anticipates August 2026 ELPIS II readout while shifting to an asset-light partnering model

LGVN

Earnings Call Insights: Longeveron (LGVN) Q1 2026 Management View “After I took on the role as CEO in February, we embarked on 2 immediate critical tasks, a comprehensive review of the company's assets, development and strategic plan and attracting new investm…

May 13, 8:31 PM EDT

Insight Molecular Diagnostics expects about $0.25M Q2 2026 revenue while projecting second-quarter cash burn above $9M

IMDX

Earnings Call Insights: Insight Molecular Diagnostics (IMDX) Q1 2026 Management View "Since submitting GraftAssureDx to the FDA in late March, we've had a high degree of engagement from them and expect that, that will continue as we move through the review pro…

May 13, 4:28 PM EDT

Earnings Snapshot: Inovio Pharmaceuticals' Q1 shows EPS beat; net loss $19.7M improves as R&D costs fall

INO

Earnings Snapshot (Seeking Alpha) More on Inovio Pharmaceuticals Inovio Pharmaceuticals, Inc. (INO) Presents at World Federation of Hemophilia World Congress - Slideshow Inovio: 'Hold' As Upcoming PDUFA For INO-3107 Is Major Inflection Point Inovio Pharmaceuti…

May 13, 4:08 PM EDT

Medicenna launches marketed public offering of securities

MDNAFMDNA:CA

Medicenna Therapeutics ( MDNA:CA ) on Wednesday said it launched a marketed public offering of securities, with the size, pricing, and terms of the offering to be determined through discussions with sole agent Bloom Burton Securities . The clinical-stage immun…

May 13, 4:01 PM EDT

COMPASS outlines 1 to 2-month FDA review goal as it targets launch readiness by year-end

CMPS

Earnings Call Insights: COMPASS Pathways (CMPS) Q1 2026 Management View CEO Kabir Nath said the quarter was “validated by the confirmation of a rolling NDA submission and review and the award of a Commissioner's National Priority Voucher or CNPV,” adding, “we…

May 13, 2:03 PM EDT

BeOne wins FDA accelerated nod for Beqalzi in lymphoma

ONC

BeOne Medicines ( ONC ) announced on Wednesday that the U.S. Food and Drug Administration granted accelerated approval for its lymphoma therapy, Beqalzi, pending the outcome of an ongoing, confirmatory study. The approval allows the Switzerland-based firm to m…

May 13, 1:07 PM EDT

Replimune surges day after FDA Commissioner Makary resigns

REPL

design master Replimune ( REPL ), which has been critical of the FDA over its application for a melanoma treatment, is up ~30% Wednesday, the day after FDA Commissioner Marty Makary tendered his resignation. Makary left his position Tuesday amid reported press…

May 13, 12:27 PM EDT

These are the 10 most heavily shorted stocks in the market right now

RHUPST

matejmo As speculative trades continue to fuel the 2026 market rally, heavily shorted stocks have remained firmly in focus. Recent data highlighted by Charles Schwab’s Liz Ann Sonders showed that Goldman Sachs’ “Most Short Rolling” basket has surged 24.7% year…

May 13, 11:52 AM EDT

Protalix reaffirms $78M-$83M 2026 revenue outlook following $25M Elfabrio milestone

PLX

Earnings Call Insights: Protalix BioTherapeutics (PLX) Q1 2026 Management View “During the quarter, we received a $25 million milestone from Chiesi, following the European Commission approval of Elfabrio's every 4 weeks dosing regimen,” and “we ended the first…

May 13, 11:22 AM EDT

Ironwood Pharma drops after CFO transition

IRWD

Ironwood Pharmaceuticals ( IRWD ) lost ~12% on Wednesday after the bowel disease drugmaker announced the appointment of an interim chief financial officer following the resignation of its current CFO, Gregory Martini. On Friday, Martini, who also served as a s…

May 13, 10:11 AM EDT

PDS Biotech outlines VERSATILE-003 amendment targeting interim PFS with approximately 250 patients

PDSB

Earnings Call Insights: PDS Biotechnology Corporation (PDSB) Q1 2026 Management view Dr. Frank Bedu-Addo (President, CEO & Director) said the quarter’s “major focus was on advancing our clinical programs,” and handed the program update to the CMO, pointing…

May 13, 8:47 AM EDT

Whitehawk Therapeutics secures $87.5M PIPE financing

WHWK

Whitehawk Therapeutics ( WHWK ) announced on Wednesday that it has entered into a securities purchase agreement for an $87.5M private investment in public equity, or PIPE, financing, before deducting placement agent fees and other private placement expenses. T…

May 13, 8:20 AM EDT

Palvella Therapeutics approved for transfer to Nasdaq Global Market

PVLA

Palvella Therapeutics ( PVLA ) said Nasdaq approved the transfer of its common stock listing from the Nasdaq Capital Market to the Nasdaq Global Market, effective May 13. The company’s shares will continue trading under the ticker “PVLA.” CEO Wes Kaupinen said

May 13, 5:53 AM EDT

Thiel-backed Varda to launch United Therapeutics’ drugs into orbit for microgravity testing

UTHR

mihailomilovanovic/E+ via Getty Images Varda Space Industries on Wednesday announced a collaboration with United Therapeutics Corporation ( UTHR ) to explore the use of microgravity to develop improved formulations of treatments for rare pulmonary disease. Var…

May 13, 4:21 AM EDT

Curis anticipates TakeAim CLL initial 5-patient dosing by mid-2026 while projecting cash runway into second half of '27

CRIS

Earnings Call Insights: Curis, Inc. (CRIS) Q1 2026 Management View "We continue to make steady progress in our TakeAim Lymphoma study in primary CNS lymphoma" and said the TakeAim Lymphoma study is "a single-arm registrational study with an ORR endpoint" evalu…

May 13, 1:58 AM EDT

Mirum Pharmaceuticals prices $600M senior notes

MIRM

Mirum Pharmaceuticals ( MIRM ) priced a private offering of $600M aggregate principal amount of 0.00% convertible senior notes due 2032. The initial purchasers have a 13-day option to buy up to an additional $90M notes. Mirum plans to use about $475M