Penny stock player Adamis gets another CRL for high-dose naloxone as shares crater
The FDA has once again shut the door on micro cap biotech Adamis Pharmaceuticals’ high dose naloxone injection.
Regulators handed down the program’s second CRL in nearly 12 months, Adamis announced Monday, sending the penny stock spiraling. The new rejection came as a result of new chemistry, manufacturing and controls issues, though Adamis noted that none of the problems stemmed from the “extractables and leachables testing” problems that caused the first thumbs down.
“To me, it is very surprising to have new issues brought up this late in the review process,” CEO Dennis Carlo said in a statement. “We believe the comments and recommendations stated in the CRL can be addressed and overcome.”
Investors shunned shares at the news, sending Adamis $ADMP stock plunging roughly 41% in Monday trading.
The San Diego-based biotech works on specialty products, seeking to develop lower-cost alternatives to drugs already on the market. Adamis’ high-dose naloxone injection was aimed at treating opioid overdoses, as products like Narcan and Evzio generally use less than Adamis’ proposed 5 mg/0.5 mL dose.
Adamis re-submitted its application in May, about six months after first being turned away. Carlo said at the time that he felt the additional data addressed all the issues related to the FDA’s letter, and the company had entered into a distribution agreement for the program that would have, pending approval, totaled up to $26 million in upfront cash and milestone payments.
But regulators evidently saw something they didn’t like — again. Both CRLs for this candidate have now dealt with CMC concerns, and Adamis has requested a Type A meeting to resolve any outstanding questions.
This is not the first Adamis program to face rejection at the FDA. Back in February 2019, the agency handed back the company’s application for a lower-cost erectile dysfunction drug, saying Adamis did not provide enough data for a review. The experimental drug was a fast-disintegrating version of tadalafil, the same active ingredient in Eli Lilly’s Cialis.
Adamis’ main product is an epinephrine injectable called Symjepi, which is used to treat allergic reactions and anaphylactic shock similar to Mylan’s blockbuster Epipen. The plan was to use the same delivery system for their naloxone injection as Symjepi. The biotech is also developing cheaper alternatives in a range of acute respiratory diseases, such as Covid-19, influenza, asthma and COPD.