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Tuesday, October 7, 2025

Envoy Medical Cuts Capital Needs After FDA OKs Final Stage Of Cochlear Implant Trial

Envoy Medical Inc. (NASDAQ:COCH) announced on Tuesday that it has received U.S. Food and Drug Administration (FDA) approval to expand its pivotal clinical trial for the fully implanted Acclaim cochlear implant to the final stage, based on promising three-month data from the first 10 patients.

The FDA's approval of the expansion request removes a previously uncertain timing variable and allows the company to solidify its path toward regulatory approval.

As a result, the company has shortened its estimated timeline by three to six months and expects to complete full enrollment by the early first quarter of 2026.

The updated timeline to commercialization and other improved efficiencies has allowed management to cut its anticipated capital needs by $10-$15 million.

The first stage consisted of 10 participants at five clinical trial sites in the United States.

All 10 patients completed their three-month milestone without reported serious adverse events (SAEs) or unanticipated device effects (UADEs).

In addition, the preliminary clinical data effectively characterized that the investigational Acclaim cochlear implant can achieve effectiveness for its proposed intended use, which was a required condition of expanded trial enrollment being approved by the FDA.

The fully implanted Acclaim cochlear implant was tested in these participants at the three-month visit in the "cochlear implant only" condition and without using a hearing aid.

The second and final stage of the clinical trial will consist of an additional 46 participants at seven clinical trial sites within the U.S.

Of the estimated 2.8 million U.S. adults eligible for cochlear implants, it has been estimated that fewer than 5% currently receive them.

In other words, this data indicates that approximately 95% of the adults in the United States who could benefit from a cochlear implant have not received one.

Envoy Medical believes one of the primary reasons for this is that most people would prefer not to have a bulky medical device attached to their head telegraphing their hearing disability, which is the case with current partially-implanted cochlear implants.

By eliminating external wearable hardware, the Acclaim is designed to overcome practical adoption barriers that have long plagued market penetration in the cochlear implant industry.

https://finance.yahoo.com/news/exclusive-envoy-medical-cuts-capital-114608207.html

CDC Says COVID-19 Vaccination Now Up To Each Individual

by Zachary Stieber via The Epoch Times (emphasis ours),

The Centers for Disease Control and Prevention no longer broadly recommends COVID-19 vaccination. The agency now says that each person should take a range of factors into account, and consult with their doctor, before receiving a shot.

“Informed consent is back,” Jim O'Neill, the CDC’s acting director, said in a statement on Oct. 6 after accepting advice from the CDC’s vaccine advisory panel. “CDC’s 2022 blanket recommendation for perpetual COVID-19 boosters deterred health care providers from talking about the risks and benefits of vaccination for the individual patient or parent. That changes today.”

The official term for the updated posture is shared clinical decision-making. Under other tiers, vaccination is recommended for everyone or everyone in a certain age or risk group.

“Shared clinical decision-making recommendations are individually based and informed by a decision process between the health care provider and the patient or parent/guardian,” the CDC states on its website.

The CDC for years recommended virtually all people aged 6 months and older receive a COVID-19 vaccine, along with updated versions on an annual basis.

Around 44 percent of people aged 65 or older received a COVID-19 vaccine in late 2024 or early 2025, according to CDC data. About 14 percent of adults aged 18 to 49, 13 percent of children, and 10 percent of health care workers received a vaccine during that time.

Under orders from Health Secretary Robert F. Kennedy Jr., the agency in May stopped recommending COVID-19 vaccination for healthy children and pregnant women.

The Advisory Committee on Immunization Practices, the CDC’s vaccine advisory panel, in September unanimously said that the CDC should change from its near-universal recommendation to shared clinical decision-making, in part because panel members said data supporting vaccine effectiveness is weak.

“At best, the additional protection provided by a seasonal booster is moderate and of short term,” Retsef Levi, chair of the panel’s COVID-19 immunization workgroup, said during the meeting.

Members also said that they were concerned about side effects the vaccines can cause, including myocarditis, a form of heart inflammation.

The panel’s advice is typically accepted by the CDC.

The Food and Drug Administration recently withdrew emergency authorization for the COVID-19 vaccines.

In updated approvals, it cleared the shots for people who are at least 6 months old who have one or more risk factors, as well as for people 65 and older.

Two of the shots are made by Moderna. One is made by Pfizer and BioNTech. The other is made by Novavax.

Some outside groups, including the American Academy of Pediatrics, still recommend COVID-19 vaccination for broader populations, including all children aged 6 to 23 months.

https://www.zerohedge.com/political/cdc-says-covid-19-vaccination-now-each-individual

'2024 Drug Designations Take First Steps Amid Uncertain Benefits'

Cell and gene therapy experts question where the FDA designation fits in an environment that features a range of intersecting regulatory perks.

The FDA’s recently created advanced manufacturing technology designation has a clear goal: Facilitating drug development. However, as the program approaches its first birthday, questions remain about how the chemistry, manufacturing and controls (CMC)–focused designation will interact with other regulatory statuses and what it will mean for companies engaging with the agency.

Congress mandated the creation of the AMT designation in the Food and Drug Omnibus Reform Act of 2022. The designation was devised for novel technologies that substantially improve the manufacturing process, including by reducing development time and supporting the production of certain drugs affected by supply disruptions. Lawmakers told the FDA to expedite filings supported by AMT statuses and to allow applicants to reference or rely on the designations in their submissions.

The FDA shared more information about the designation in final guidance published late last year. Officials said key benefits include early interactions regarding the development and manufacture of drugs using a designated AMT. According to the guidance, the FDA intends to provide timely advice, engage in additional communication and prioritize applicant interactions involving the use of a designated AMT.

Those benefits appear to overlap with the advantages provided by other regulatory statuses available to cell and gene therapy manufacturers, such as the Regenerative Medicine Advanced Therapy designation. The qualifying criteria for fast track, breakthrough and regenerative medicine designations differ, but the level of overlap between the evidence requirements was a source of confusion for the industry when the FDA first proposed RMAT. Companies progressively collect the evidence needed to receive each designation. For example, uniQure’s Huntington’s disease gene therapy received fast track status in 2019, RMAT in 2024 and breakthrough designation in 2025.

The AMT qualifying criteria are distinct in that they are focused on manufacturing rather than efficacy, but insiders have observed that potential users of the designation may have the preclinical or clinical data to secure other statuses. Michael Paglia, chief technology officer at ElevateBio BaseCamp, told BioSpace that many cell and gene therapy companies that he works with already have designations that allow early interactions with the FDA.

Paglia and other experts have ideas about what AMT designations may mean to companies that already have expedited access to the FDA. But with only three companies having publicly announced their receipt of an AMT designation, and with drug developers yet to put the benefits of the new program to use, the details remain uncertain.

Resolving the Uncertainty

Companies with multiple designations may be able to interact more with the agency by setting up meetings focused on specific areas, Paglia said. While noting that he has yet to see how AMT designations will work in practice, Paglia sketched out a theory for how companies can use multiple designations to discuss narrow sets of questions with specific FDA representatives.

“What we’re guessing is that you have the ability now to really focus RMAT-type interactions on clinical, preclinical, [biologics license applications], commercialization—and then the AMT on more the CMC side of things,” Paglia said.

However, Don Fink, a regulatory expert at Dark Horse Consulting, has doubts about whether AMT designations will open up more access to the FDA. For companies already on the expedited pathways, he told BioSpace, “I don’t think it makes that big a difference, personally, because you’re not going to get a new category of meetings.”

The consultant and former FDA employee outlined hypothetical ways that AMT designations could affect access. For example, if two companies with RMATs request meetings at the same time and only one has an AMT designation, does the FDA prioritize the company with the AMT? Fink does not know the answer yet.

He also speculated about how the FDA would prioritize requests for engagement when one company has an RMAT and another company has an AMT. The consultant predicted that RMAT designation will take precedence, explaining that “once you get one of these expedited designations, you pretty much have your way with the agency for meetings.” The FDA has said an AMT designation does not affect the time needed to review approval filings. By contrast, candidates with product, fast track, breakthrough therapy or RMAT designation may be eligible for expedited review.

While those scenarios suggest AMT designations may have limited impact, Fink speculated that when the FDA is reluctant to grant a Type D meeting, which provides timely feedback critical to move the program forward, the agency may feel obligated to accept the request if the applicant has an AMT designation and questions related to CMC.

A New Card in the Deck

The FDA will now sort through how to apply AMTs on a center-by-center basis, Fink said, and there may be differences in how the designation is used across the agency. A clearer picture may start to emerge in the coming months. Ori Biotech CEO Jason Foster recently said he expects the company’s partners to start using its recently granted AMT designation to support clinical trial filings in the next six months.

There remains the possibility that the designation will be most impactful as a promotional tool for technology providers. Paglia said the designation could be “great for marketing.” Similarly, Fink noted the potential for the status, alongside similar designations, to help companies attract customers and investment.

“Some people just collect them like playing cards. They get a fast track because they can. That’s easy. Then they’ll get an RMAT. Then they’ll get breakthrough [designation], if they can even go further with their clinical data,” Fink said. “They all essentially allow for the same things.”

Fink foresees a possible future in which the designation has little impact beyond those benefits. “Three to five years out it may be just another thing that you have, a shiny nickel coin that doesn’t really make one difference,” he said.

https://www.biospace.com/policy/amt-designation-takes-first-steps-amid-uncertain-benefits

Pfizer Beat Out Two Other Metsera Suitors for Takeover

Of the three highest bidders, Pfizer’s purchase proposal for Metsera was the lowest, regulatory documents reveal. The New York pharma, however, offered the smoothest transaction with the greatest likelihood of success.

Pfizer got the prize of Metsera and its obesity pipeline with its $4.9 billion takeover last month, though the pharma by no means had the highest offer.

The competition for Metsera was fierce, as is detailed in a proxy statement filed with the SEC on Monday. Indeed, the initial roster of suitors included seven companies, of which three stood out, including Pfizer. The SEC document did not name the two other bidders, only referring to them as Party 1 and Party 2.

“Pfizer’s takeout of Metsera appears to have been a competitive process with multiple bidders attempting to acquire the company,” analysts at BMO Capital Markets told investors in a Monday note. “High bids from Parties 1 and 2 suggest that both companies view Metsera’s pipeline as having significant and possibly blockbuster potential.”

Pfizer’s offer, which eventually won out, priced Metsera at $47.50 per share with $22.50 in contingent value rights (CVR) tacked on, yielding an overall per-share bid of $70. This was far below the other offers on the table, according to the proxy statement. Party 1 priced the biotech’s common stock at $50 apiece, plus a $37 CVR, resulting in an overall value of $87 per share. Meanwhile, the second bidder priced Metsera at $95 per share: $47.50 in Party 2 stock plus a $47.50 CVR, convertible to Party 2 stock.

Over the course of the negotiations, however, Party 2 withdrew from the race on Sept. 3, citing “an unanticipated recent internal development,” which rendered the bidder unable to issue its stock.

Between Party 1 and Pfizer, the financial terms were leaning in the former’s favor—enough that Metsera reached out and “encouraged” Pfizer to “improve its proposal in light of the competitive dynamics” of the other offers the biotech was fielding. Metsera had previously told Pfizer that it wanted the pharma to up its CVR rate to $35.00—which would have bumped the deal value up to $82.50 per share—but Pfizer declined to budge.

Despite maintaining its lower bid, Pfizer had the advantage of time and presented the option that was most likely to result in a smoother, quicker transaction.

In its proxy filing, Metsera noted that dealing with Party 1 “presented a variety of risks.” Chief among these are what the biotech called “regulatory risks” that could eventually lead to the failure of, or a significant delay in, the agreement—though it did not detail out what such risks were. In particular, Metsera was wary that the closing of the transaction could be pushed back “by up to 24 months” and that the CVR “might only be paid after an extended period of time, if at all.”

According to BMO, these unstated “regulatory risks” suggest that Party 1 could also be a major player in obesity, with the analysts particularly pointing to Novo Nordisk.

“In our view, Party 1 is likely Novo given its dominant position in the GLP-1/amylin market, the December 2024 Cagrisema REDEFINE-1 miss that sent NVO shares into free fall, and Metsera acquisition discussions occurring shortly thereafter,” they wrote. And while the apparent Novo offer posed too much risk for Metsera, the pharma’s alleged interest “makes us more confident” in the eventual Pfizer-Metsera acquisition, BMO added.

Ultimately, these regulatory risks—and their potential consequences to the company, including difficulties in retaining talent and in advancing its pipeline—pushed Metsera to accept Pfizer’s bid. To support its unanimous recommendation of the deal, the biotech’s Board wrote that Pfizer’s offer “is more favorable to Metsera stockholders than the potential value that might result from other strategic options available.”

https://www.biospace.com/business/pfizer-beat-out-two-other-metsera-suitors-for-takeover