3 Biotech Stocks Throwing Their Weight Around, and Another that Wants to Help You Lose Yours

DENVER, Sept. 30, 2026 (GLOBE NEWSWIRE) -- (247marketnews.com) -- The biotech market is heading into a stretch of unusually dense catalysts, with regulatory meetings, Phase 2 readouts, potential Phase 3 transitions and blockbuster cardiometabolic data converging for NeOnc Technologies Holdings (NASDAQ:NTHI), Connect Biopharma (NASDAQ:CNTB), Valion Bio (NASDAQ:VBIO), and Eli Lilly and Company (NYSE:LLY).

NeOnc: November FDA Meeting Puts NEO212 Under the Microscope

NeOnc (NASDAQ:NTHI) is moving toward a potentially important regulatory checkpoint with an in-person End-of-Phase 1 Type B meeting with the U.S. Food and Drug Administration scheduled for November 17, 2026. The meeting concerns NEO212, the company's investigational oral perillyl alcohol-temozolomide conjugate being developed for central nervous system cancers. NeOnc says it intends to seek FDA feedback on the proposed patient population, Phase 2 design, endpoints, dose selection and evidence that could ultimately support a marketing application.

NEO212 arrives at that discussion after completion of Phase 1 dose escalation. The company has identified 610 mg as its recommended Phase 2 dose after escalation reached a protocol-defined maximum tolerated dose of 810 mg. NeOnc has also highlighted individual patient observations from the early-stage program, including a reported approximately 60% tumor reduction and 21 months of disease control in one patient with recurrent IDH1-wild-type, MGMT-methylated glioblastoma.

The NEO212 catalyst is unfolding alongside a second clinical story. NeOnc's NEO100 program produced topline Phase 2a data in recurrent IDH1-mutant high-grade glioma, with the company reporting six-month progression-free survival of 48.9% versus a prespecified 20% benchmark and median overall survival of 26.09 months. The company has said it intends to engage FDA regarding a potential registrational pathway for NEO100.

The financial and corporate backdrop is also changing. NeOnc completed a $15 million registered direct offering in September and subsequently redeemed all 6,000 outstanding Series A convertible preferred shares for $6 million in cash, eliminating the associated potential common-share conversion. At the same time, executives disclosed approximately $629,000 of open-market purchases following the NEO100 readout. CEO Amir Heshmatpour alone purchased another 35,000 shares for approximately $115,400 on September 15.

Connect Biopharma: COPD Data Throws New Phase 3 Catalyst onto the Board

Connect Biopharma (NASDAQ:CNTB) delivered one of the day's most consequential small-cap biotech catalysts with preliminary topline results from its Phase 2 Seabreeze STAT COPD study of rademikibart. In 159 adults with COPD, type 2 inflammation and an eosinophil count of at least 300 cells/μL, the company reported an 81% reduction in treatment failure through Week 4 versus placebo, with a reported p-value of 0.0122. New moderate-to-severe COPD exacerbations were reduced by 85%, while the company reported a 100% reduction in new emergency-department visits or hospital admissions for new exacerbations through Week 4.

The numbers give Connect a fresh regulatory narrative because treatment failure was the study's primary endpoint. The company reported 11 treatment failures among 81 placebo patients versus two among 78 rademikibart patients in its preliminary analysis. A separate analysis based strictly on 28 days showed a 77% reduction in events with a p-value of 0.0373. The company also reported a clinically meaningful 70 mL greater improvement in FEV1 at Week 4, although that comparison was not statistically significant, with a reported p-value of 0.1607.

The COPD result follows September data from the companion Seabreeze STAT asthma study, where rademikibart produced a 66% reduction in treatment failure over 28 days and a statistically significant 130 mL greater improvement in post-bronchodilator FEV1 at Day 7. The asthma treatment-failure endpoint itself did not reach statistical significance, with p=0.153, making the COPD readout particularly important to the broader development story. Connect has said it intends to engage the FDA regarding a Phase 3 registrational program covering acute exacerbations in COPD and asthma.

CEO Barry Quart described the COPD data as “overwhelming evidence of the potential benefit” of early rademikibart treatment and said the company plans to engage FDA as soon as feasible regarding a Phase 3 program.

Valion Bio: Needle-Free Entolimod Program Opens New Front

Valion Bio (NASDAQ:VBIO) is attacking a very different market problem: how to make a potential radiation countermeasure easier to deploy. On September 30, Valion and Shear Kershman Laboratories announced completion of formulation work for an oral mucosal version of Entolimod using SKL's BioViscid delivery platform. The formulation is designed to deliver Entolimod through the lining of the mouth rather than through injection, creating a potential second delivery pathway for the company's lead program.

The strategic appeal is straightforward. Acute radiation syndrome can present an extraordinary logistics challenge, particularly in emergency, military or mass-casualty environments. Valion says the next critical question is whether the oral mucosal formulation can produce measurable systemic exposure in the bloodstream and what pharmacokinetic profile that exposure produces.

Entolimod's broader development history gives the formulation story additional context. Valion is developing the molecule under the FDA Animal Rule framework and has previously reported animal data involving both hematopoietic and gastrointestinal radiation injury. The company has also been engaging with U.S. government agencies and has reported work involving the Armed Forces Radiobiology Research Institute and NIAID on an efficacy protocol for gastrointestinal acute radiation syndrome. In August, Ukraine's Ministry of Health accepted Valion's Entolimod dossier for formal review under its Regulatory Equivalence Pathway, with the company saying a decision could potentially come in the fourth quarter.

The company's corporate structure is evolving alongside the drug program. Valion brought in new leadership, including Dean Zikria as interim CEO, while continuing to develop Entolimod and its next-generation TLR5 agonist Entolasta. Its wholly owned Velocity Bioworks subsidiary also gives the company an in-house biomanufacturing operation in San Antonio. The oral mucosal milestone therefore adds another development vector to a platform already pursuing government preparedness, oncology supportive care and manufacturing opportunities.

Eli Lilly: Retatrutide Data Raises Obesity Drug Race Stakes

Eli Lilly and Company (NYSE:LLY) enters the final days of September with one of the biggest clinical stories in the entire pharmaceutical sector. The company's Phase 3 TRIUMPH-2 study of investigational retatrutide reported substantial weight loss and A1C reductions in adults with obesity or overweight and type 2 diabetes. At 80 weeks, the 12 mg group had an average body-weight reduction of 20.8%, or 49.6 pounds, while the 9 mg group averaged 19.1% and the 4 mg group 12.7%. Among participants with baseline BMI of at least 35, the 12 mg group averaged a 23.4% reduction, or 60.8 pounds.

The glycemic data add another layer. Average A1C reductions were 1.4%, 1.6% and 1.5% for the 4 mg, 9 mg and 12 mg groups, respectively, versus 0.2% for placebo. Lilly reported that 39.3% of participants receiving 12 mg reached an A1C below 5.7%, compared with 4.4% for placebo, while 52.0% of the 12 mg group achieved at least 20% weight loss. The highest dose also produced reductions in triglycerides, non-HDL cholesterol, systolic blood pressure, waist circumference and hsCRP.

The development story still has a regulatory finish line. Retatrutide remains investigational and is not approved for human marketing. Lilly says it plans to submit a Biologics License Application to the FDA in the first quarter of 2027, while additional Phase 3 trials are evaluating retatrutide across obesity, type 2 diabetes, obstructive sleep apnea, knee osteoarthritis pain, cardiovascular and renal outcomes, and metabolic dysfunction-associated steatotic liver disease. The initial TRIUMPH Phase 3 program has enrolled more than 5,800 participants, according to Lilly.

Meanwhile, Lilly is not waiting for retatrutide to define its cardiometabolic strategy. The company already has FDA-approved Foundayo (orforglipron), a once-daily oral GLP-1 medicine for obesity, and Zepbound (tirzepatide). FDA approved Foundayo on April 1, 2026, and Lilly has been expanding its manufacturing footprint, including a $6.5 billion Houston facility intended to produce Foundayo's active pharmaceutical ingredient. On September 29, Lilly also released an indirect treatment comparison in type 2 diabetes suggesting greater weight loss and A1C reduction with Foundayo 17.2 mg than oral semaglutide 25 mg.

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