As previously reported, TD Cowen upgraded Milestone Pharmaceuticals (MIST) to Buy from Hold with an $8 price target after Cardamyst nasal spray was approved by the FDA for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia to sinus rhythm in adults. The label is clean with no market-limiting warnings or monitoring requirements, notes the analyst, who also points out that Cardamyst will be available in retail pharmacies in Q1 of 2026 with a wholesale acquisition cost of ...

Core Insights - Milestone Pharmaceuticals (NASDAQ:MIST) is currently viewed as a promising investment opportunity, with analysts at Jefferies raising the price target from $1 to $2, maintaining a Hold rating [1][2]. Company Overview - Milestone Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing cardiovascular medicines for self-administration by patients with episodic heart conditions [3]. Product Development and Sales Prospects - The price target increase is attributed to the company's confidence in its upcoming PDUFA, with a product launch scheduled for early next year [2]. - The company anticipates that the first quarter of next year will mark the beginning of significant sales, supported by the deployment of 60 representatives targeting up to 15,000 high-volume prescribers [2]. - Milestone is developing Etripamil, a nasal-administered, short-acting calcium channel blocker aimed at treating paroxysmal supraventricular tachycardia (PSVT) [2].

Market Overview - U.S. stocks traded mostly lower, with the Dow Jones index dropping over 250 points, down 0.60% to 44,382.58, while the NASDAQ rose slightly by 0.06% to 20,643.06, and the S&P 500 fell 0.23% to 6,266.23 [1] - European shares were lower, with the eurozone's STOXX 600 dipping 1.07%, Spain's IBEX 35 Index falling 0.99%, London's FTSE 100 down 0.47%, Germany's DAX 40 slipping 0.81%, and France's CAC 40 declining 0.94% [5] - Asian markets closed mixed, with Japan's Nikkei down 0.19%, Hong Kong's Hang Seng up 0.46%, China's Shanghai Composite gaining 0.01%, and India's BSE Sensex falling 0.83% [6] Company Earnings - WD-40 Co. (WDFC) reported better-than-expected earnings for its third quarter, although sales missed estimates. The company raised its FY2025 EPS guidance but narrowed its sales forecast [2] Stock Movements - MiNK Therapeutics, Inc. (INKT) shares surged 526% to $48.40 following a publication in Oncogene [8] - Ruanyun Edai Technology Inc. (RYET) shares increased by 19% to $18.37 after signing a strategic partnership with Confucius Institute at Prince Sultan University [8] - Signing Day Sports, Inc. (SGN) shares rose 98% to $2.4350 due to advancements in its business combination with One BlockchAIn [8] - Milestone Pharmaceuticals Inc. (MIST) shares dropped 41% to $1.5050 after announcing a public offering [8] - Federal Agricultural Mortgage Corporation (AGM) shares fell 11% to $175.20 following the announcement of the departure of its Chief Financial Officer [8] - TransMedics Group, Inc. (TMDX) shares decreased by 10% to $112.93 [8] Commodities - In commodity news, oil prices increased by 2.6% to $68.28, gold rose by 1.5% to $3,375.80, silver gained 4.1% to $38.830, while copper fell by 0.9% to $5.5425 [4]

Core Viewpoint - Milestone Pharmaceuticals has submitted a response to the FDA's Complete Response Letter regarding its New Drug Application for CARDAMYST™ (etripamil) nasal spray, aimed at treating acute episodes of paroxysmal supraventricular tachycardia (PSVT) in adults, with a new PDUFA date expected within the year [1][2]. Company Overview - Milestone Pharmaceuticals Inc. is a biopharmaceutical company focused on developing innovative cardiovascular solutions to enhance the lives of individuals with complex heart conditions [4]. - The company emphasizes understanding unmet patient needs and improving patient experiences through new treatment approaches that allow for self-management [4]. Product Information - Etripamil is the lead investigational product of Milestone, designed as a novel calcium channel blocker nasal spray for the rapid treatment of symptomatic episodes of PSVT and atrial fibrillation with rapid ventricular response (AFib-RVR) [3]. - If approved, CARDAMYST™ will be the first self-administered therapy for the rapid termination of PSVT episodes, providing patients with greater control over their condition [2][3]. Regulatory Interaction - A recent Type A meeting with the FDA was deemed productive, providing necessary guidance for the resubmission of the NDA [2]. - The FDA's acceptance of the response and the determination of the new PDUFA date will occur within the next thirty days, with a review period expected to be between 2 to 6 months from resubmission [1].

Core Viewpoint - Milestone Pharmaceuticals (MIST) received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for CARDAMYST (etripamil) nasal spray, intended for treating paroxysmal supraventricular tachycardia (PSVT) [1][2] Regulatory Issues - The CRL does not raise concerns about the clinical safety or efficacy of etripamil but highlights two Chemistry, Manufacturing, and Controls (CMC) issues that need to be resolved before approval [2][11] - The first issue involves nitrosamine impurities, with the FDA requesting additional data based on new draft guidance issued after MIST's NDA submission [3] - The second issue relates to a facility inspection involved in the drug's release testing, which underwent a change in ownership during the NDA review, necessitating a compliance evaluation [4] Market Reaction - Following the CRL issuance, MIST's shares fell by 66.2%, with a year-to-date loss of 67.8%, contrasting with the industry's growth of 2.2% [2][7] - Analysts remain cautiously optimistic about the drug's prospects, suggesting a potential commercial launch in 2026, delayed from the original expectation of mid-2025 [8][11] Company Response and Financial Position - MIST has expressed its intent to request a Type A meeting with the FDA to clarify the path forward and is committed to addressing the outstanding issues [9] - As of December 31, 2024, MIST reported $69.7 million in cash and short-term investments, providing a runway for ongoing development efforts, although additional capital may be needed if delays continue [10] Investor Perspective - The CRL is viewed as a temporary obstacle rather than a fundamental rejection of CARDAMYST's therapeutic potential, with the absence of clinical concerns being a positive indicator for eventual approval [11]