News

(RTTNews) - This week's biotech landscape witnessed regulatory approvals across the U.S. and Europe, alongside FDA rejections, acquisitions, and positive data readouts spanning multiple therapeutic areas, including Wilson's Disease, Ovarian cancer and stiff person syndrome.

Let's unpack the specifics.

FDA and EU Approvals & Rejections

Sanofi (SNY) won expanded FDA approval for Tzield?in stage 2 type 1 diabetes, now covering children as young as one year old. The CD-3-directed antibody remains the only therapy to delay progression to stage 3 disease, with the decision supported by the PETITE-T1D Phase 4 study.

SNY closed Thursday's trading (April 24, 2026) at $47.53, up 1.34%.

Royal Philips (PHG)?received U.S. FDA 510(k) clearance for its Rembra platform, including Rembra CT, Rembra RT, and Areta RT system. The technologies aim to expand access to faster, more precise imaging across frontline care and cancer treatment planning, with features such as an 85 cm bore and high-throughput capacity supporting up to 270 exams per day. The clearance strengthens Philips' diagnostic imaging and radiation oncology portfolio.

PHG closed Thursday's trading at $27.63, down 2.16%.

Sanofi (SNY) and Regeneron secured FDA approval for Dupixent?to treat children aged 2-11 with chronic spontaneous urticaria who remain symptomatic and uncontrolled by antihistamines. The decision, based on LIBERTY-CUPID data, expands Dupixent's reach beyond adults and adolescents, marking its ninth approved indication across allergy-related conditions.

SNY closed Thursday's trading at $47.53, up 1.34%.

Alpha Tau Medical Ltd. (DRTS) received FDA approval for an IDE supplement, allowing expansion of its IMPACT pilot study of Alpha DaRT in pancreatic cancer to include patients treated with Gemcitabine with Abraxane. The intratumoral alpha-radiation therapy is now being evaluated alongside both leading first-line chemotherapy regimens, broadening its development path in unresectable and metastatic disease. Enrolment is expected to complete in Q3 2026.

DRTS closed Thursday's trading at $7.98, down 1.24%.

Cipla Wins FDA Nod for the First Generic Ventolin HFA

Cipla Limited (CIPLA) and its U.S. subsidiary received FDA approval for Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, the first AB-rated generic of Ventolin HFA. Indicated for bronchospasm?and?exercise induced bronchospasm in patients aged four and older, the approval strengthens Cipla's U.S. respiratory portfolio and expands its leadership in inhalation therapies. The product will be manufactured at Cipla's new inhalation facility in Massachusetts

CIPLA closed Thursday's trading at INR 1,295.00, down 0.83%.

Regeneron Pharmaceuticals (REGN) secured FDA accelerated approval for Otarmeni, the first gene therapy for genetic hearing loss linked to OTOF gene variants. The decision, supported by pivotal CHORD trial data, makes Otarmeni available at no cost to clinically eligible U.S. patients. The therapy uses an adeno-associated virus vector to restore hearing in pediatric and adult patients with severe sensorineural?loss.

REGN closed Thursday's trading at $766.02, up 2.60%.

AbbVie (ABBV) announced it received a Complete Response Letter from the FDA for its Biologics License Application for TrenibotulinumtoxinE (TrenibotE) for the treatment of moderate to severe glabellar lines, citing manufacturing process issues. The agency did not raise safety or efficacy concerns and did not request additional clinical studies. AbbVie plans to submit a comprehensive response in the coming months.

ABBV closed Thursday's trading at $200.95, up 0.22%.

Grace Therapeutics, Inc. (GRCE)?received a Complete Response Letter (CRL) for its NDA of GTx-104, an IV Nimodipine?formulation for aneurysmal subarachnoid haemorrhage (aSAH). The agency cited chemistry, manufacturing, and non-clinical deficiencies, including packaging and toxicology data, but did not question efficacy. Grace plans to resubmit after addressing the issues, supported by Phase 3 STRIVE-ON trial data showing reduced hypotension versus oral Nimodipine.

GRCE closed Thursday's trading at $2.35, down 45.48%.

Deals

Vystar Corporation (VYST) has entered into a binding letter of intent to acquire a 50% interest in R3alm Inc., a compliance-focused AI and Web3 financial ecosystem.

Under the proposed transaction, R3alm would receive approximately 8,500 shares of Vystar Series B preferred stock, and both parties would jointly manage and develop the platform. Closing is expected within 60 days, subject to approval conditions.

VYST closed Thursday's trade at $0.33, up 3.13%.

Eli Lilly and Company (LLY) and Kelonia Therapeutics, Inc., announced a definitive agreement for Lilly to acquire Kelonia and Kelonia shareholders will receive up to $7 billion in cash, including an upfront payment of $3.25 billion and subsequent payments upon achievement of certain clinical, regulatory, and commercial milestones.

The acquisition may expand Lilly's genetic medicine capabilities with in vivo gene delivery and integration technology. The transaction is expected to close in the second half of 2026, subject to conditions.

LLY closed Thursday's trade at $917.65, down 0.42%

QuidelOrtho Corporation (QDEL), a diagnostics company, announced that it has completed the acquisition of LEX Diagnostics, the developer of the FDA-cleared LEX VELO system, for a cash consideration of approximately $100 million.

QuidelOrtho stated that the acquisition of LEX would accelerate growth in its point-of-care molecular diagnostics market, and the company anticipates launching the LEX VELO system in the U.S. later this year, with global expansion planned.

QDEL closed Thursday's trade at $11.24, down 5.55%.

Amneal Pharmaceuticals, Inc. (AMRX), a generic medicine and biosimilar manufacturer, announced that it has entered into a definitive agreement to acquire Kashiv BioSciences in a transaction that includes $375 million of cash and $375 million of equity payable at closing and up to $350 million in potential regulatory milestones and royalty payments.

The transaction positions Amneal to capitalise on more than $300 billion in global biologic drug sales expected to lose exclusivity over the next decade.

The transaction is expected to close in the second half of 2026, subject to approval conditions.

AMRX closed Thursday's trade at $12.65, down 1.33%.

Genenta Science S.p.A. (GNTA)?has signed a definitive agreement to acquire a controlling stake in Sòphia High Tech S.r.l., a manufacturer of precision mechanical components used in European space and defence programs

As per the agreement terms, Genenta will invest 6.0 million euros in two tranches. The first tranche will give the company a 19.9% stake, while completion of the second tranche will increase ownership to 51%, making Sophia High Tech a majority-owned subsidiary.

GNTA closed Thursday's trade at $0.70, down 1.69%.

Clinical Trials - Breakthroughs & Setbacks

Monopar Therapeutics Inc. (MNPR), a clinical-stage biopharmaceutical company, announced new analyses of promising results from FoCus, a pivotal Phase 3 trial evaluating ALXN1840 (Tiomolibidate choline, TMC), an investigational oral daily treatment for Wilson Disease.

The Phase 3 FoCus trial evaluated the safety and efficacy of ALXN1840 for the treatment of Wilson disease compared with standard-of-care treatments.

ALXN1840 showed rapid and sustained copper mobilisation over 48 weeks, thus meeting its primary endpoint, and also demonstrated a favourable safety and tolerability profile across 645 patient-years of follow-up in 266 patients, with a median follow-up of 2.58 years.

MNPR closed Thursday's trading at $53.24, down 0.11%.

Kyverna Therapeutics, Inc. (KYTX), a late-stage clinical biopharmaceutical company, announced positive primary analysis results from its registrational Phase 2 trial, KYSA-8, of miv-cel (KYV-101), a CD19 CAR T-cell product candidate for stiff person syndrome.

The trial met its primary endpoint, demonstrating a statistically significant improvement in the Timed 25-Foot Walk?(T25FW) at week 16, with a median improvement of 46% from baseline.

The trial met all secondary endpoints, with significant mean improvements in mRS, HAI, DSI, and HSS of -0.8, -1.6, -1.5, and -3.2 points, respectively.

Miv-cel demonstrated a well-tolerated and manageable safety profile.

KYTX closed Thursday's trade at $9.36, up 4.53%.

Zymeworks Inc. (ZYME) presented new Phase 1 data for its folate receptor alpha (FRa)-targeting antibody-drug conjugate (ADC), ZW191, demonstrating encouraging anti-tumour activity in heavily pretreated ovarian and endometrial cancers, with responses observed regardless of FRa expression levels.

In platinum-resistant ovarian cancer, ZW191 achieved a confirmed objective response rate (cORR) of 56% across all dose levels, with tumour regression in 68% of patients and disease control in 94%. At doses of 6.4-9.6 mg/kg, responses were even stronger.

Investigators noted the safety profile was manageable with no unexpected signals.

ZYME closed Thursday's trade at $27.43, down 3.38%.

Johnson & Johnson (JNJ) announced new data from the Phase 3 Vivacity-MG3 study and ongoing open-label extension in a broad population of antibody-positive adults with generalised myasthenia gravis, reinforcing the efficacy, sustained disease control and safety profile of IMAAVY.?

Through 120 weeks of follow-up, IMAAVY delivered sustained clinical improvements and reductions in total IgG in antibody-positive adult patients, including anti-AChR+ and anti-MuSK+.

JNJ closed Thursday's trade at $230.65, up 2.01%.

Novo Nordisk (NVO) has reported positive topline results from the PIONEER TEENS?trial that evaluated oral Semaglutide in 132 children and adolescents aged 10-17 years with type 2 diabetes.

Oral semaglutide demonstrated a superior reduction in HbA1C, a measure of blood sugar control over placebo in the trial and showed a well-tolerated safety profile consistent with previous Novo Nordisk semaglutide trials.

The therapy delivered a statistically significant and superior reduction in blood sugar compared with placebo at 26 weeks, the primary endpoint.

NVO closed Thursday's trade at $38.52, down 1.61%.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.