Brexanolone

Dive Brief:Sage Therapeutics, a brain drug developer thats dealt with a series of clinical setbacks, has agreed to be acquired by Supernus Pharmaceuticals in a deal worth $561 million.Supernus on Monday said it would pay $8.50 per share for Sage, an offer valuing shares at a roughly 27% premium to their previous closing price. The deal also includes a contingent value right worth up to $3.50 per share if certain sales and commercial milestones related Sages lone product, the postpartum depression drug Zurzuvae, are met.Sage earlier this year turned down a $7.22-per-share offer from Zurzuvae development partner Biogen and sued the company, arguing it was being undervalued. The company has been evaluating strategic alternatives, a process that included a search for a buyer, ever since.Dive Insight:Sage has gone through a roller coaster ride since its founding more than a decade ago.Launched by Third Rock Ventures and run for many years by biotech veteran Jeff Jonas, the company aimed to develop brain drugs for a variety of conditions, from epilepsy and tremors to Huntingtons disease. The company went public in 2014 to support that work and saw its share price swell to nearly $200 apiece a few years later as a pair of depression medicines advanced through testing. It brought to market not only the first medicine for postpartum depression, Zulresso, but the first pill for the condition, called Zurzuvae. It cut a multibillion-dollar partnership deal with Biogen, too.But Zulresso, a 60-hour infusion, never generated significant sales and Sage stopped marketing it at the end of the year. And the company had initially hoped to bring Zurzuvae to market for major depressive disorder a much larger opportunity but changed course and laid off staff after U.S. regulators asked for additional testing.Sage has suffered setbacks elsewhere, too, with experimental drugs failing studies in epilepsy, tremors, Alzheimers, Huntingtonsand Parkinsons disease over the years. Company shares closed on Friday at $6.70 apiece and have fallen so low in recent months that Sages board accused Biogen of lowballing the company with an earlier bid.The deal with Supernus feelslike an unremarkable outcome for a company that was once one of the hottest stories in brain drug research, wrote Stifel analyst Paul Matteis in a note to clients Monday.Matteis added that, for investors, though, the acquisition is a good end to the Sage story given the host of challenges facing the company.In a separate note, RBC Capital Markets Brian Abrahams called Supernus offer fair given the considerable time it would have taken for Sage to become profitable.Abrahams also wrote that there is a very low likelihood that Sage hits the majority of the sales targets that would bump up its sale price. Sage stockholders would get $1 per share if Zurzuvae hits $250 million in sales in the U.S. by 2027, and similar payouts if U.S. drug sales reach $300 million by 2028 and $375 million by 2030.Zurzuvae generated $72 million in U.S. sales in 2024. Biogen and Sage split U.S. profits. '

New Drug Submission filed by Lipocine's licensing partner Verity Pharma Over 700,000 total prescriptions written annually for testosterone replacement therapy (TRT) in Canada, representing large commercial opportunity SALT LAKE CITY, June 9, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics, today announced that its licensing partner, Verity Pharma, filed a New Drug Submission (NDS) for TLANDO® in Canada. TLANDO is the first and only oral testosterone replacement therapy (TRT) option approved by the US Food and Drug Administration (FDA) that does not require dose titration. "Canada represents an attractive market for TLANDO and the filing of the NDS by Verity Pharma represents an important next step in making the product available there," said Mahesh Patel, CEO of Lipocine. "We believe that, if approved, the introduction of this new and highly differentiated oral TRT option has the potential to drive significant market gains." There are over 700,000 prescriptions written annually in Canada for TRT, and approximately 50% of this patient population is covered through private insurance. In addition, there are limited promotional activities surrounding currently available TRTs, which could provide an opportunity for TLANDO to capture a significant share of this large and growing market. In January 2024, Lipocine and Verity Pharma entered into an exclusive license agreement under which Verity Pharma gained the commercial rights to TLANDO® in the United States and Canada. About TLANDO TLANDO is approved by the US FDA as a testosterone replacement therapy (TRT) in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). It was developed using Lipocine's proprietary Lip'ral drug delivery technology platform. For full prescribing information, please visit . About Lipocine Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics. Lipocine has drug candidates in development as well as drug candidates for which we are exploring partnerships. Our drug candidates represent enablement of differentiated, patient friendly oral delivery options for favorable benefit to risk profile which target large addressable markets with significant unmet medical needs. Lipocine's clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101 for the potential treatment of epilepsy, LPCN 2203 an oral candidate targeted for the management of essential tremor, LPCN 2401 an oral proprietary anabolic androgen receptor agonist, as an adjunct therapy to incretin mimetics, as an aid for improved body composition in obesity management and LPCN 1148, a novel androgen receptor agonist prodrug for oral administration targeted for the management of symptoms associated with liver cirrhosis. Lipocine is exploring partnering opportunities for LPCN 1107, our candidate for prevention of preterm birth, LPCN 1154, for rapid relief of postpartum depression, LPCN 2401 for obesity management, LPCN 1148, for the management of decompensated cirrhosis, and LPCN 1144, our candidate for treatment of metabolic dysfunction-associated steatohepatitis (MASH). TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate developed by Lipocine, is approved by the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. For more information, please visit . Forward-Looking Statements This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding our product candidates and related clinical trials, our development of our product candidates and related efforts with the FDA, including with respect to LPCN 1154, our P3 safety and efficacy study relating to LPCN 1154, the timing and potential results of the safety and efficacy study relating to LPCN 1154, potential partnering of our product candidates with third parties, and the potential uses and benefits of our product candidates. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that we may not be successful in developing product candidates, we may not have sufficient capital to complete the development processes for our product candidates or we may decide to allocate our available capital to other product candidates, we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets, safety and efficacy studies, including those relating to LPCN 1154, may not be successful or may not provide results that would support the submission of a NDA, the FDA may not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals and our ability to utilize a streamlined approval pathway for LPCN 1154, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at . Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. SOURCE Lipocine Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED