FDA Extends Review Time: Regeneron EYLEA HD Faces Q4 2025 Decision for Expanded Uses

Regeneron Pharmaceuticals (NASDAQ: REGN) announced FDA review extensions for two EYLEA HD® (aflibercept) 8 mg regulatory submissions to Q4 2025. The extensions affect the prefilled syringe CMC Prior-Approval Supplement and a supplemental Biologics License Application for RVO treatment and expanded dosing options.

The delay stems from a recent FDA inspection of Catalent Indiana LLC, a third-party manufacturer acquired by Novo Nordisk. Novo Nordisk submitted a comprehensive response in August 2025 to address FDA observations. EYLEA HD remains available in vial form, with approved dosing intervals of 8-16 weeks for wAMD and DME patients, and 8-12 weeks for DR patients after initial monthly doses.

https://www.stocktitan.net/news/REGN/eylea-hd-aflibercept-injection-8-mg-applications-for-expanded-u-s-yo18xkfppbu1.html

Meta Artificially Inflated Ecommerce Ad Metrics, Former Employee Claims

 Meta, the parent company of Facebook and Instagram, has been accused of artificially inflating the performance metrics of its ecommerce advertising product, Shops ads, according to a whistleblower complaint filed Wednesday in a U.K. employment tribunal.

The complaint, brought by Samujjal Purkayastha, a former product manager on Meta’s Shops ads team, alleges the company misled advertisers by overstating the return on ad spend (ROAS), making its newer ad offering appear more effective than competing products, ADWEEK reports.

Allegations of Inflated Metrics

According to the filing with the London Central Employment Tribunal, Meta allegedly boosted Shops ads’ performance numbers by:

• Counting shipping fees and taxes as part of total revenue

• Subsidizing bids in ad auctions to secure more prominent placement

• Applying undisclosed discounts to give the impression of stronger results

Internal reviews conducted in early 2024 revealed Shops ads’ ROAS had been inflated between 17% and 19%, according to the complaint. Meta’s other ad products - as well as competitors like Google - calculate ROAS using net figures, excluding shipping and taxes. Without the added fees, the filing claims, Shops ads performed no better than Meta’s traditional ad products.

“This was significant,” the complaint states. “In addition to the ROAS performance metric being overstated by nearly a fifth, it meant that, rather than having exceeded our primary target, the Shops Ads team had in fact missed it once the figure was reduced to take account of the artificial inflation.”

Meta’s Push After Apple’s Privacy Changes

The filing links these alleged practices to a broader effort inside Meta to recover from the effects of Apple’s App Tracking Transparency (ATT) feature, rolled out in 2021.

Apple’s policy limited access to iOS user data, a cornerstone of Meta’s ad business. Former Meta CFO David Wehner warned during a 2021 earnings call that the change could cost the company “on the order of $10 billion.”

By encouraging advertisers to use Shops ads, which kept transactions inside Meta’s apps, the company could collect more first-party purchase data and reduce its reliance on Apple’s tracking permissions.

According to Purkayastha, Meta began subsidizing Shops ads in auctions, sometimes by as much as 100%, ensuring they appeared more often than other ad formats. This increased visibility, artificially boosted conversions and made Shops ads seem like a stronger investment.

Purkayastha joined Meta in 2020 as part of the Facebook Artificial Intelligence Applied Research team before being reassigned to the Shops Ads team in March 2022. He remained at the company until February 19, 2025.

The complaint says Purkayastha repeatedly raised concerns in meetings with senior leadership between 2022 and 2024, questioning the accuracy of Shops ads’ reported results. He claims the company continued using the disputed methodology despite internal objections.

The complaint also points to Meta’s tracking tools as part of its strategy to maintain advertising performance after Apple’s privacy changes.

• Aggregated Event Measurement (AEM1), introduced in April 2021, used machine learning to estimate conversions while respecting users who opted out of tracking.

• AEM2, rolled out shortly thereafter, allegedly linked in-app activity to browsing and purchases on third-party sites using personal identifiers like names, emails, phone numbers, and IP addresses.

According to ADWEEK;

In the complaint, Purkayastha said he believed AEM2 bypassed restrictions imposed by Apple’s privacy framework, though it mitigated much of the loss of data from the privacy changes.

Purkayastha was terminated from Meta in February 2025, according to the complaint. His filing with the employment tribunal is part of an application for interim relief, requesting that his former position be reinstated. 

Meta has not yet commented on the complaint. A request for comment from ADWEEK, which first reported the filing, was not returned by the time of publication.

https://www.zerohedge.com/technology/meta-artificially-inflated-ecommerce-ad-metrics-former-employee-claims

83% Response Rate: I-Mab's Novel Gastric Cancer Drug Shows Promise in Phase 1

I-Mab (NASDAQ: IMAB) reported Q2 2025 financial results and business updates, highlighting significant progress in its oncology pipeline. The company's lead drug givastomig showed promising Phase 1b results with an 83% objective response rate in combination with immunochemotherapy for first-line gastric cancers.

I-Mab strengthened its financial position through an underwritten offering raising $61.2 million, resulting in a pro-forma cash balance of $226.8 million as of June 30, 2025. This funding is expected to sustain operations through Q4 2028. The company reported reduced R&D expenses of $3.3 million for Q2 2025, down from $5.2 million in Q2 2024, and a net loss of $5.5 million for Q2 2025.

Key upcoming milestones include topline data from givastomig's Phase 1b dose expansion study expected in Q1 2026. The company also acquired Bridge Health, strengthening its intellectual property portfolio for givastomig.

https://www.stocktitan.net/news/IMAB/i-mab-reports-second-quarter-2025-financial-results-and-provides-ypm4szpsgh4d.html

Jazz pays Saniona $42.5M to add preclinical prospect to epilepsy ensemble

 Jazz Pharmaceuticals has struck a deal to bolster its epilepsy ambitions, paying Saniona $42.5 million upfront for a preclinical asset designed to address problems faced by GSK’s withdrawn drug Potiga.

Dublin-based Jazz is on course to turn its existing epilepsy drug Epidiolex into a blockbuster this year. The Saniona deal gives the company global rights to the next-generation epilepsy drug candidate SAN2355. Saniona began (PDF) GMP manufacturing and toxicology studies for the asset in March, putting it on track to finalize a clinical trial application data package by the end of the year. 

Jazz will pay milestones as SAN2355 advances, starting with a $7.5 million fee tied to the initiation of the first phase 1 trial. The fee is part of $192.5 million in development and regulatory milestones included in the deal. Jazz is also on the hook for up to $800 million in commercial milestones based on product sales.

SAN2355 is a selective small molecule activator of Kv7.2/Kv7.3 potassium channels. GSK’s Potiga showed that potassium channel openers can improve outcomes in patients with partial-onset seizures more than a decade ago, only for regulators to restrict use after reports of discoloration of the skin and retina. The company withdrew the product in 2017, citing (PDF) “very limited uptake” of the drug.

Xenon Pharmaceuticals has advanced another potassium channel opener, azetukalner, into phase 3 trials in the belief that the structure of its molecule has fixed the problems that sank Potiga. But Saniona saw a need to go further, specifically by avoiding the Kv7.4/Kv7.5 activation it has identified as the likely driver of urinary retention seen in some recipients of azetukalner and Potiga.

SAN2355 selectively activates Kv7.2/Kv7.3 while blocking Kv7.5, a design that Saniona has predicted will reduce urinary retention and adverse effects on the central nervous system. Equally, because SAN2355 is from a different chemical series than Potiga, the biotech sees little risk of skin and retinal discoloration. 

Convincing Jazz of the merits of SAN2355 gives Saniona its second deal in nine months. The biotech put cash into SAN2355 after licensing essential tremor candidate SAN711 to Acadia Pharmaceuticals for $28 million upfront last year.

https://www.fiercebiotech.com/biotech/jazz-pays-saniona-425m-add-preclinical-prospect-epilepsy-ensemble

Pfizer in another Paxlovid lawsuit from Enanta

 If you don’t succeed at first, try again – in separate regions. That’s the motto Enanta Pharmaceuticals is following, at least, after disclosing it has sued Pfizer in Europe over a patent infringement relating to Covid-19 treatment pill Paxlovid (nirmatrelvir/ritonavir).

In June 2022, Enanta filed a lawsuit against Pfizer in a US district court in Massachusetts, claiming that the big pharma company infringed on a patent describing protease inhibitors invented by its scientists. Enanta has now followed that up with another filing in Europe, making the same accusation.

Since being emergency authorised in 2021, anti-viral Paxlovid has generated Pfizer more than $26bn in global revenue. This includes a staggering $18.9bn in 2022 when Covid-19 cases were still prevalent. Despite waning demand for Covid-19 treatments, the pill still brought in $1.2bn in 2024, buoyed by government orders.

However, Enanta – known for co-developing hepatitis C virus treatment glecaprevir/pibrentasvir with AbbVie – believes Pfizer designed Paxlovid via unlawful means.

The US biotech stated it is “seeking a determination of liability for use and infringement of European Patent No. EP 4 051 265 (the ’265 Patent) in the manufacture, use and sale of Pfizer’s Covid-19 antiviral, Paxlovid”.

In an emailed statement to Pharmaceutical Technology, a Pfizer spokesperson said: “We are confident in our intellectual property (IP) surrounding Paxlovid and will respond in due course in court.”

The lawsuit, filed in the European Union’s (EU) Unified Patent Court (UPC), targets Pfizer’s commercial activity in the 18 countries of the EU. The company confirmed the ’265 patent in question is the European counterpart of US patent number 11,358,953 (the ’953 Patent) that is the centre of the US lawsuit.

Although it is technically ongoing, Enanta’s US lawsuit hit a major roadblock. In December 2024, a federal judge in Massachusetts sided with Pfizer, granting that the ‘953 patent is invalid. Enanta confirmed at the time it would appeal the decision, adding it “believes strongly in the merits of our case”.

Pfizer reported strong Q2 2025 results this month, bucking a tepid earnings window that gripped the wider pharma industry. Sales for the Paxlovid grew 71% while the Covid-19 vaccine Comirnaty revenue surged 95%.

However, the legal challenge posed by Enanta marks the second issue Pfizer has had to firefight this week. The big pharma company reported a Phase III trial failure for a sickle cell disease candidate purchased as part of a $5.4bn takeover of Global Blood Therapeutics in 2022.

https://finance.yahoo.com/news/pfizer-battles-another-paxlovid-lawsuit-165337183.html

Xoma adds fading Mural Oncology to portfolio of struggling biotechs

 Xoma Royalty is ravenous for biotechs, and the Bay Area licensing aggregator has found its next meal in Mural Oncology. Xoma is set to acquire Mural for $2.035 per share, for a total value of about $36 million, the company announced on Aug. 20.

The price is a premium on the $1.80 per share that Mural was trading at when the market closed on Aug. 19, but by 9:45 a.m. ET on Aug. 20, the biotech's share price had jumped 16% to $2.08.

If Mural somehow reaches the acquisition’s closing date with more than the estimated $36.2 million, shareholders will be paid up to $0.205 more per share to be sure they get back that extra cash.

The deal is set to close by the end of 2025, according to the release, after which Mural will be housed in a new Xoma subsidiary called XRA 5 Corp.

The writing has been on the wall for Mural since April, when the cancer company’s IL-2 variant nemvaleukin alfa failed a phase 2 melanoma trial. That clinical flop followed similar struggles in a phase 3 trial in platinum-resistant ovarian cancer. Mural responded by laying off 90% of its staff and launching a hunt for strategic alternatives.

"The transaction agreement with Xoma Royalty announced today is the result of a thorough and wide-ranging strategic review process, conducted with the support of our legal and financial advisors,” Mural CEO Caroline Loew, Ph.D., said in the release. “We believe that this transaction, which is supported by our board, achieves the goal of this strategic review process, which was to maximize shareholder value.”

Mural marks Xoma’s third biotech acquisition of the month. On Aug. 4, the royalty collector announced it was buying Takeda spinout HilleVax and Dutch outfit Lava Therapeutics. HilleVax went awry in July 2024, when the company’s sole clinical-stage candidate failed a phase 2b trial in norovirus-related acute gastroenteritis, while Lava’s bispecific gamma delta T-cell engager flopped in a phase 1 trial at the end of last year.

And in June, Xoma snagged San Diego-based Turnstone Biologics at a bargain price of less than $8 million. That deal came after Turnstone was forced to drop its last clinical program due to manufacturing costs.

Xoma’s primary business is buying rights to royalties and milestones, paying biotechs cash upfront to support their assets in exchange for longer-term revenue streams.

https://www.fiercebiotech.com/biotech/xoma-adds-fading-mural-oncology-portfolio-struggling-biotechs

Novavax cut to Underperform by B of A

 In a significant development for Novavax (NVAX, Financial), B of A Securities has downgraded the stock's rating from "Neutral" to "Underperform" as of August 20, 2025. Analyst Alec Stranahan also adjusted the price target for NVAX, lowering it from $9.00 to $7.00 USD, representing a 22.22% decrease.

https://www.gurufocus.com/news/3071110/novavax-nvax-downgraded-by-b-of-a-securities-with-price-target-lowered-nvax-stock-news