AcelRx Pharmaceuticals wants to put a tough few years behind it. After failing to crack the pain market, the biotech has shifted its focus to a pipeline led by a blood thinner and adopted a new name, Talphera, to reflect the revised strategy.
The value of AcelRx has fallen sharply in recent memory, dropping 62% over the past year and 98% over the past five years to leave the company with a market cap of below $15 million. The five-year time frame covers the period after the approval of the sublingual pain drug Dsuvia. AcelRx won approval in 2018 but failed to turn the opioid into a major product, generating sales of $1.8 million in 2022.
Alora Pharmaceuticals acquired the drug for $1.1 million last year, moving AcelRx away from its earlier focus on pain. Following the transaction, AcelRx’s goals were to win approval tforhe pre-filled ephedrine syringe, Fedsyra, and a lyophilized formulation of nafamostat, Niyad. Neither product is a pain drug.
CEO Vincent Angotti commented on the pivot on a quarterly results conference call with investors in November, explaining that the business “has evolved quite a bit over the past 18 months, and we're now a very different company than we were just a few years ago.” Now, the company has come up with a new name to go with its new focus. Here’s the thinking behind the name.
“Talphera was derived from ‘talisman’, meaning a strong leader, and reflects the new ‘pharmaceutical era’ for the company. The company's new mission at Talphera is to support healthcare providers by developing and commercializing products in medically supervised settings that deliver advances in care to patients,” Talphera said in a statement.
The roadmap includes a filing for approval of Niyad in the second half of the year. Talphera said the asset would be “the first-ever regional anticoagulant approved by the FDA for use in the dialysis circuit” if it is approved. Cash is tight, though. Talphera ended September with $13.4 million and warned investors it expected to “need additional capital to fund our planned operations” within 12 months of its filing.